“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

Lauren McClinton: At first, I had sort of been wary of biosimilars, because they kind of felt like a generic or a not-so-great option. But after having a conversation with my rheumatologist, she explained that the biosimilar that I would be taking is very, very similar to the original one, and the difference really lies more so in the kind of the branding and the naming of it as opposed to the actual efficacy of the medication.

Zoe: Welcome to Breaking Down Biosimilars- a podcast that brings light to biosimilars and helps you better understand the role they play in your healthcare, now and in the future. I’m Zoe Rothblatt,

Conner: And I’m Conner Mertens, Both of us are Patient Advocates and Community Outreach Managers at GHLF.

Conner: Our goal is to introduce you to biosimilars, what they are, how they get approved, their potential savings and what promise they hold.

Zoe: We also hear from a few people who’ve been taking biosimilars about their own experiences. And we cover some of the common myths about biosimilars, and try to separate fact from fiction.

Conner: So Zoe, let’s face it…biosimilars are kind of a mystery to a lot of people.

Zoe: Yep, that’s right. And Conner, we work at GHLF and do this for a living and I often still get confused.

Conner: Me too. That’s why we are doing this podcast, so we can break it down together and learn what biosimilars are all about.

Zoe: There’s certainly a lot to break down, and a lot of terms along the way.  And unfortunately, it seems like lot of the confusion was created to make patients unsure about these medications. So let’s remember to stop each other if we’re getting lost.

Conner: For sure…

Zoe: For this first episode, we’ll focus on some of the common questions about biosimilars. Like what’s the difference between a biosimilar and a generic? What’s the different between a biosimilar and a biologic? And we’ll also hear from a few healthcare providers and patients about how they’re using biosimilars.

Conner: So let’s dive in… There’s a lot of confusion between biosimilar drugs and generic drugs. These days, if you walk into a drugstore, you can see lots of generic drugs on the shelf next to brand-name drugs. They’re a lot cheaper ‘cause they don’t have fancy packaging or expensive advertising. So why aren’t there any biosimilar drugs on the shelves?

Zoe: Well, first of all, the stuff you see on drugstore shelves are all “small-molecule” drugs – they’re made from simple chemical structures that are fairly easy to replicate. So, creating a generic of one of those is pretty straightforward. But many other conditions like Crohn’s disease, rheumatoid arthritis or psoriatic arthritis are a lot more complex, and the drugs used to treat them are a lot more complex. Those kinds of drugs are biological drugs – they’re made up of living organisms like proteins, cells, tissues, and antibodies.

Conner: Okay, so that means if you’re going to try to replicate a biologic drug, it’s not so easy, right?

Zoe: Right, because if you’re trying to replicate something made from living organisms, it’s a lot more complex that re-creating a simple chemical structure. So biosimilars won’t be 100% exact copies, but they will be very, very close. That explains the name – “bio” because they replicate biological drugs, and “similar” because they’re not actual duplicates.

Conner: Do biosimilars work the same way as their original, or reference, biologic? drugs?

Zoe: Well, maybe we should hear from an expert. But before we do that, I’m noticing a term!

Conner: Right! You caught me. Originator biologic – this is the biologic that the biosimilar is based off of. It is also referred to as the reference biologic or refence product.

Zoe: Great. Now back to the question at hand – do biosimilars work the same as their originator biologic? I talked to Dr. Sameer Awsare, an internal medicine physician who’s also part of the Kaiser-Permanente Health Network. I asked him to break down the differences between generics and biosimilars.

Awsare: Biosimilars are biologics. Whether they’re the originator product or the biosimilar, they’re both biologics. And we can kind of compare that to what generics are for brand name drugs, but it’s important to understand that generic are copies of brand name drugs.

Biologics and biosimilars are both made from living organisms. So they cannot be exact copies of each other, but it’s important to understand that they’re actually highly similar to each other. And to put it simply, it just means that they work just as good and patients. And there’s really no meaningful difference in terms of safety, purity, or potency. For example, if we have a patient with rheumatoid arthritis and they take the original biologic or the biosimilar, their rheumatoid arthritis will improve with either of them.

Zoe: In Dr. Awsare’s case, it took some time before Kaiser-Permanente oncologists felt comfortable with biosimilars. So they conducted their own internal study.

Awsare: We had 700 patients who were taking the original biologic, and then we have the next 700 taking the biosimilar, and our oncologists were able to see that there was really no difference in how the patients did with either of those medications.

Once they were able to see that we have been on a tear with biosimilars, every new one that has come on, we have been able to get adoption of from our physicians. It’s also important to give patients time to understand what biosimilars are, because I could be doing well on the original biologic product.

Conner: Seems like getting buy-in from patients about biosimilars is super-important here.

Zoe: Absolutely. One of those patients is Lauren McClinton. She told me that a medication she was taking had more or less stopped working, so she had a conversation with her rheumatologist about changing her treatment. In discussing a treatment plan, her rheumatologist recommended a different medication for which there is a biosimilar.

Lauren: At first, I had sort of been wary of biosimilars, because they kind of felt like a generic or a not-so-great option. But after having a conversation with my rheumatologist, she explained that the biosimilar that I would be taking is very, very similar to the original one, and the difference really lies more so in the kind of the branding and the naming of it as opposed to the actual efficacy of the medication.

My experience learning about biosimilars was just like, this is a great option that I think will work for you from a medical professional that I really trusted. And learning that it was more of an issue in regards to what would be covered under my insurance and less of a concern in regards to medical efficacy or like how well it would help me.

Zoe: How are you feeling now one year into being on this biosimilar?

Lauren: The number one greatest impact that is had has been helping manage my fatigue. Before taking a biosimilar I was able to curb my joint pain and symptoms like that through other types of medication. But I never really found that anything sort of really was able to tackle the fatigue and it’s not something that you notice because fatigue sort of sneaks up on you and you don’t really notice that you’re feeling tired every day until you’re not tired every day. And that was really stupendous.

Conner: So, it seems Lauren has found the right treatment plan and had a good experience so far with taking a biosimilar, But it still seems like a lot of people have never heard of them.

Zoe: Well, that’s probably because biosimilars are so new – they’ve only been around in the U.S. since 2015. And even a lot of doctors and pharmacists are still learning about them. I also talked to Dr. Simon Helfgott, a rheumatologist from the Boston area who’s been in practice for 35 years.

Helfgott: I’m the Director of Education and fellowship training at Brigham and Women’s Hospital, which is a large teaching hospital with a large rheumatology fellowship. I’ve been in charge of that program since about 2004. I’m very interested in medical education, Medical Teaching, but I also love seeing patients and getting that hands-on relationship with patients where you can see their joints examined and listen to their stories, and hopefully try to help them as well.

Zoe: Dr. Helfgott says there was a lot of thought put into coming up with the term ‘biosimilars.’

Helfgott: The term biosimilar was carefully crafted many years ago, because the concern was, we didn’t want to overstate it, we didn’t want to call these bio-identical products, because they’re not exactly carbon copies of the originator product, but they’re not generic, like a pill would be generics. For example, if somebody was on – I’ll use the example of Lipitor, which was the most commonly prescribed cholesterol lowering drug for many years. And it’s a generic is atorvastatin. And then when Lipitor, went off patent to atorvastatin came on the market. And by now I’m going to guess they’re probably five or six, if not more, forms of atorvastatin and they’re all generic.

It’s sort of similar with biosimilars are happening, although it has not happened to that degree. But a biosimilar is a bit different because a biological drug is different. A biological drug is a product that was carefully designed and created to attack one portion of the immune system that is overly active and causing a disease state to occur. And to create these biological drugs took quite a bit of skill and ingenuity. And these are structures that are two or even three dimensional in shape, meaning you can’t just put together a bunch of compounds like you would in a pill, and then just mash it up into a pill and expect it’s going to work. These drugs vary quite a bit on how they’re structured and how they’re created. For that reason, we refer to them as biological drugs, because they have this specific biological effect that each one particularly has.

Conner: That really explains it well. But Zoe, it still seems like biosimilars are nowhere near as prevalent in the marketplace as generic drugs. Do we know how many are actually out there?

Zoe: There aren’t a whole lot just yet, and we’ll get to this later in the series. But Dr. Helfgott says there are interesting developments on the horizon.

Helfgott: Right now, we are dealing primarily with drugs that are at least in the rheumatology sphere, there are drugs that are all infused – given intravenously. There are biosimilars that will be self-injectable, but they have not yet reached the market. But they will in the next 12 to 18 months. And with the development of the jak kinase drugs which are pills, we consider them in the same family as biologicals. There will be oral versions of jak kinase drugs when those patents go off, which is also just a few years away from now.

Zoe: Next time on ‘Breaking Down Biosimilars,’ we’ll look at the process of getting a biosimilar drug approved by the FDA.

Conner: We’ll explore how long that process takes, and what a manufacturer needs to do to prove that a biosimilar drug is just as effective as a biologic drug. We’ll also dive into why naming conventions for biosimilars are so important.

Zoe: We hope you learned something new about biosimilar and how they compare to generics drugs. We’d love to hear from you about your reactions to this first episode. Send your email to [email protected]

Conner: Thanks for listening to Breaking Down Biosimilars – a podcast that brings light to biosimilars and helps you better understand the role they play in your healthcare, now and in the future. If you liked this episode, give us a rating and write a review Apple Podcasts. It’ll help more people like you find us. I’m Conner Mertens.

Zoe: And I’m Zoe Rothblatt. See ya next time.

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

Criswell Lavery: The FDA is obviously heavily invested in making sure that the drugs that they’re representing, that they’re putting their seal of approval on are being used to the best of their ability. And a big part of that is making sure that they are doing the most that they can to see that drugs are administered safely, accurately, and with all the support that they need.

Zoe: Hi, and welcome to ‘Breaking Down Biosimilars,’ part of the family of podcasts from the Global Healthy Living Foundation. I’m Zoe Rothblatt.

Conner: And I’m Conner Mertens. Both of us are Patient Advocates and Community Outreach Managers at GHLF. During this series, we cover everything you need to know about biosimilars – what they are, how they work, and who should take them.

Zoe: We also hear from a few people who’ve been taking biosimilars about their own experiences. And we cover some of the common myths about biosimilars, and try to separate fact from fiction.

Conner: So Zoe, this time we’re looking at what it takes to get a biosimilar drug approved by the Food and Drug Administration, or for short, the FDA in the US.

Zoe: Yes, and we’re really going to focus on how this impacts you as a patient, we’ll start by looking at what goes into getting a biosimilar approved, and along the way introduce concepts about how biosimilars are regulated by the FDA, and what this means for patients in real life taking a biosimilar. It gets a bit confusing with some terms that pop up, like interchangeability.

Conner: But not to worry, we’ll talk it through like we always do.

Zoe: Exactly, and we’ll hear from a few experts along the way that can help fill in some of the gaps for us, especially when it comes to the big terms.

Conner: Biosimilars started getting approved around 6 years ago in the U.S., right?

Zoe: Yup. Even though they’ve been on the market in Europe for the last 16 years or so. So here in this country, biosimilars are kind of like the ‘new kids in town.’ And while the approval process is a bit less time-consuming than for a reference drug, it’s still a big deal.

Conner: So how exactly does it work?

Zoe: Well, one nice thing is that when a drug company or manufacturer proposes a new biosimilar, it doesn’t have to go through all of the same clinical testing as the biologic drug that it’s based on. That can save time and money.

Conner: How’s that?

Zoe: Scientists already know the properties of reference drugs because of all the clinical trials that were conducted for them initially. This explains that term “reference drug” which is talking about the biologic that the biosimilar is based on. The biologic serves as a reference for the biosimilar, so they don’t need to go through all the work again because the blueprint is there.

Conner: Got it. So there’s no need to repeat all those same trials for the biosimilars.

Zoe: Right. But the FDA is still really strict about making sure manufacturers can prove that a proposed biosimilar is just as effective as its reference drug. There are still LOTS of hoops to jump through. They have to show that the biosimilars’ active ingredients work the same way as the reference drug.

Conner: What about the inactive ingredients?

Zoe: Well, there may be slight differences in the inactive ingredients between the biologic and the biosimilar, but the biosimilar manufacturer also has to show that those won’t affect safety in any way.

Conner: That helps clear things up. I often get questions and concern from patients about the approval process. And I’m glad we are breaking it down together. That reminds me, another question I hear a lot is about how biosimilars are named, and how to tell by the name if it is a biosimilar or a biologic.

Zoe: The FDA came up with a unique naming convention for biosimilars, which can be a bit confusing. I spoke with Criswell Lavery, a clinical research coordinator at the University of Pennsylvania. I asked her to describe how the naming convention works.

Lavery: They take the generic name, the non- proprietary name, which is like for Humira, it’s adalimumab; for Enbrel, it’s etanercept, and then they add a 4-character suffix on to the end of it. This 4-character suffix doesn’t have any meaning, meaning specifically, it actually is in the writing that it cannot, it’s a group of four consonants that are just nonsense. And the reason that they do that is just because it’s a way to distinguish between the biosimilar and biologic without giving precedence to either of them. So if you’re saying that this is the original, and this is the derivative, I think that can have connotations with it. And so by giving everything a 4-character suffix that has no inherent meaning, it really is just a way to, you know, distinguish between the different types.

Conner: So Zoe, why would the FDA create a system where part of the drug’s name has no meaning?

Zoe: Well, because you may have a few biosimilars that have the same formula as a single biologic, but they’re different in very minor but very specific ways. And like we talked about in Episode One, biosimilars are drugs made from living organisms, so it’s really impossible to create 100% duplicates. And as Criswell told me, there was a lot of thought put into the naming convention with those random letters.

Zoe: So then if this doesn’t have any meaning, what meaning does it have? Does it play into safety? What does this actually in the real world have implications for patients taking these medications?

Lavery: It absolutely has implications for safety for pharmacovigilance, making sure that the right drugs are prescribed and delivered to the right patients. So even though all biosimilars have the same amino acid sequence as biologics, there can be some differences and things like packaging and delivery method. And so that can be really, really important and impactful for patients. For instance, one of the biosimilars has latex in the packaging and in the delivery system. And it’s very important to distinguish between the original and the latex delivery system because some people are allergic to latex. You can get into dangerous territory when you use mostly the brand name to refer to all of the biologics and biosimilars because the pharmacist will go based on what’s on the prescription, so if the doctor says Enbrel, they’re going to give Enbrel; By putting the 4-character suffix on there, it allows prescribers to really say this is the one that I need and this is the one that I think will be most useful for my patient.

Conner: Okay so that makes sense, let me make sure I am getting this right. Every biosimilar has a brand name, just like a biologic does. For example, the biologic Infliximab has the brand name Remicade. And the biosimilars for Infliximab also have brand names. So these are Inflectra, Renflexis and Avsola. Am I right so far?

Zoe: Yes.

Conner: See I did my homework too. And let’s say you aren’t familiar with the brand names, the way you know that it is a biosimilar is that it will say Infliximab-dyyb, for example. And each of the biosimilars have a different 4-character suffix from the other, whereas the orginal biologic will just have that core unbranded drug name.

Zoe: Exactly, So, if you are taking a biosimilar and you order your medication from the pharmacy, you can look at the label and see okay there’s the 4-character suffix next to that core name, so I know this is a biosimilar. And if it doesn’t have that 4-character suffix, you’ll know it is the biologic.

Conner: There’s a lot to pay attention here with naming, I’m glad we’re diving into this.

Zoe: Yeah, I brought this up with Criswell – about how much there is to pay attention to.

Zoe: Who is it on to make sure that the patient is getting the right drug? Seems like there’s a bunch of players here with the doctor, the pharmacist, the patient, maybe the person administering the medication? Whose role is it to make sure? Is it a group effort?

Lavery: I would say it’s definitely a group effort. A lot of pharmacists will triple check, and say, ‘Hey, you prescribed this for a patient with a latex allergy? Did you mean to do that? Are you 100% sure?’ Of course, pharmacists can’t be the last line of defense, checking everybody. So it’s also on doctors to make sure that they are educated on all the different kinds of biosimilars, and making sure that they know the difference between the brand name and the non-proprietary names, and how they’re different and why those differences are important. I think it’s on patients to be educated and to make sure they’re talking with their doctors and making sure that they are involved in their treatment as possible.

Zoe: What was that process like working with the FDA? And can you talk a little bit about what strides are being made for biosimilar development and access in the US?

Lavery: The FDA is obviously heavily invested in making sure that the drugs that they’re representing, that they’re putting their seal of approval on are being used to the best of their ability. And a big part of that is making sure that they are doing the most that they can to see that drugs are administered safely, accurately, and with all the support that they need.

They were really, really driven to understand how their naming convention was being used. And I think that’s pretty admirable that it’s not just that you’re putting out the standard and saying, ‘This is the standard, and you have to follow it.’ They follow that up with research and seeing how is it being used? How’s it being received? I think that it was, at least for me, heartening to see that the follow through was there.

Conner: So one of the goals of biosimilar drugs is to bring down costs for patients. How’s that working out so far?

Zoe: It’s still a bit early to tell, because biosimilars are relatively new to the US market. But there’s one specific aspect of the approval process that’s designed to reduce both costs and the approval timeline. It’s called ‘extrapolation.’

Conner: How did I know it was going to be a word like that?

Zoe: Maybe it’s time to call in another expert. Dr. Robert Popovian is Chief Science Policy Officer here at the Global Healthy Living Foundation, and he has tons of experience working with biosimilars manufacturers. I asked him about extrapolation.

Popovian: That means you didn’t have to demonstrate safety and efficacy in every single indication that the competitor or the originator biosimilar had. Extrapolation is extremely important. It is not done without regulatory approval, and it’s critical because if not, you’re going to inherently increase the cost of the research and development and hence, you’re not going to be able to reduce the spending for these medicines and have the ability then to pay for newer innovations that are coming down the line such as cell and gene therapies and cancer medicines and also drugs for autoimmune disorders are coming on which are much more newer.

Conner: Sounds like a good idea. It also seems like there’s a lot more to it than just a doctor saying ‘I think I’ll prescribe this biosimilar.’

Zoe: Absolutely. You know how if you go to your pharmacy, often they give you the generic version of the medication instead of the brand name for your prescription from your doctor?

Conner: Sure. I think almost everyone has had that happen.

Zoe: Well, people often wonder if that’s also true for biosimilars. There’s a name for that, too – interchangeability. This is important to highlight because as someone taking a biosimilar, this might happen to you when you go to get or order your medication, and while this isn’t happening yet for rheumatology patients, it could be in the near future.  Here’s Robert again.

Popovian: A designation of interchangeability allows a pharmacist to substitute an originator biologic with a biosimilar without having to get the permission of the physician or the prescriber, whoever the prescriber was. It has nothing to do with efficacy and safety. It’s basically a regulatory designation by the FDA. And it still allows the patients and providers and pharmacists and everybody else to use biosimilars, except that in the case that a drug has interchangeability designation, pharmacists just doesn’t have to get the approval of the prescribing physician.

Conner: So, let’s break this down with a real life example And I’ll use Infliximab for the example, since we were talking about it before with naming. Okay, here’s my understanding: If I’m taking the biologic Infliximab, and it gets this interchangeable status, I may go to the pharmacy or infusion center and get a biosimilar instead, like Infliximab-axxq (Avsola) for example. But if it didn’t have the interchangeable status, the pharmacy will have to ask my doctor before giving me the biosimilar in lieu of the biologic.

Zoe: Yes, that’s right. If given the interchangeable status, the pharmacist could substitute your Infliximab originally prescribed by your doctor with the biosimilar without first having to call your doctor for approval. Similar to that scenario with generic medication we mentioned above.

Conner: and are we seeing this happening?

Zoe: Until recently, no biosimilars had been designated as interchangeable yet. Part of the reason is that biosimilar manufacturers have to demonstrate that a patient could switch back and forth between the reference drug and the biosimilar at least three times with no differences in safety or effectiveness.

Conner: That seems like a pretty high bar. So as of now, for most biosimilars you still have to have a prescription specifically written for a biosimilar in order to get it.

Zoe: Right, except for two. In July of 2021, the FDA did approve the first biosimilar as interchangeable – Insulin Glargine.

Conner: Oh, that’s the biosimilar of the reference product Lantus, which is used to treat certain types of diabetes.

Zoe: It is. And just recently the FDA granted interchangeable status for a Humira biosimilar called Cyltezo. Not this biosimilar won’t be on the market until 2023. But once available, pharmacists will be able to substitute Cyltezo with the originator product without first consulting physicians.

Zoe: Next time on ‘Breaking Down Biosimilars,’ we’ll look at what types of patients a biosimilar could work for.

Lauren McClinton: My experience learning about biosimilars was just like, this is a great option that I think will work for you from a medical professional that I really trusted. And learning that it was more of an issue in regards to what would be covered under my insurance and less of a concern in regards to how well it would help me.

Conner: We’ll hear how physicians talk to their patients about biosimilars, and how patients decide to make the switch after having those conversations.

Zoe: We hope you learned something new about biosimilar and how they get approved in the U.S. We’d love to hear your feedback. Send your email to Br[email protected]

Conner: Thanks for listening to Breaking Down Biosimilars- a podcast that brings light to biosimilars and helps you better understand the role they play in your healthcare, now and in the future. If you liked this episode, give us a rating and write a review Apple Podcasts. It’ll help more people like you find us. I’m Conner Mertens.

Zoe: And I’m Zoe Rothblatt. See ya next time.

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

Lauren McClinton: My experience learning about biosimilars was just like, this is a great option that I think will work for you from a medical professional that I really trusted. And learning that it was more an issue in regards to what would be covered under my insurance and less of a concern in regards to how well it would help me.

Zoe: Welcome to Breaking Down Biosimilars- a podcast that brings light to biosimilars and helps you better understand the role they play in your healthcare, now and in the future. I’m Zoe Rothblatt,

Conner: And I’m Conner Mertens, Both of us are Patient Advocates and Community Outreach Managers at GHLF.

Conner: Our goal is to introduce you to biosimilars, what they are, how they get approved, their potential savings and what promise they hold.

Zoe: We also hear from a few people who’ve been taking biosimilars about their own experiences. And we cover some of the common myths about biosimilars, and try to separate fact from fiction.

Zoe: This time we’re going to talk with a few patients who’ve had to consider switching to a biosimilar, and find out what their experiences have been like.

Conner: And we’ll hear why some people were initially wary of making the switch, and what they had to do to overcome their skepticism.

Zoe: One of the people I spoke with was Sabina Netto from southern California. She was diagnosed about three years ago with psoriatic arthritis, and currently takes Inflectra, the biosimilar for Remicade.

Sabina: I didn’t latch onto the concept of biosimilar. I was on a different biologic and it wasn’t working any longer. And in the conversation with my rheumatologist, she had two suggestions, and one was another biologic that was an injection. And I was previously on one that was an injection. And then she suggested Inflectra and it was an IV infusion, because she could adjust the medication if it wasn’t working more readily than she could with the injectable. So I actually didn’t get a ton of information on what Inflectra was from my rheumatologist. I just had the two names and then she sent me a bunch of information. So in reading that and obviously Googling, the term biosimilar came up. And also, when I was searching for Inflectra, Remicade kept coming up. And so I wasn’t sure I was like, is this Remicade? Is it Inflectra? Is it like a different name? I just wasn’t sure.

And so the more I read about it, I was like, okay, this is like a generic of Remicade. And so I read more on my own about both of those drugs as you do when you’re on a new medication. And I just kind of put it in the back of my head, ‘cause I was obviously very used to the concept of generic medication and it didn’t bother me. So it didn’t really raise any red flags for me.

Conner: So, obviously, a good deal of confusion on Sabina’s part when her doctor first told her about biosimilars.

Zoe: And a lot of hesitancy, too, because it seems like Sabina wasn’t really getting a clear idea at first about what biosimilars were.

Zoe: What kinds of information did your doctor share with you and what were those conversations like?

Sabina: Now that I realize that there is hesitancy when people are on biosimilars. I would have thought there would have been a little more of a, ‘Hey, I’m suggesting this medication, it’s a biosimilar. This is what a biosimilar is,’ but there was none of that. It was just, ‘Here’s the name of the medication.’ And they send you a link to an information packet about the medication. I totally glazed over the concept of biosimilar. I just thought it was more related to the category of biologic than what it is. And so I just kind of went into it not fully understanding what the difference in the term was. And then again, when I Googled it and saw the references to Remicade, that’s when I was like, ‘Oh, that’s what that means.’

Conner: So, Sabina had to do a lot of digging on her own to learn what biosimilars are, and how they’re different from their biologics.

Zoe: Right. And it’s a two-way street. Patients have to be their own advocates, but providers need to know about all the options for biosimilars, and communicate those options to their patients. That’s what I heard from Criswell Lavery, a clinical researcher at the University of Pennsylvania.

Lavery: On the provider side, making sure that the rheumatologist, oncologist, hematologist, whatever are aware of the prescribing options. And I think a lot of that tends to be on the hospital side, just depending on the medications are available and suppliers that they’re using, and how widespread information is about the available options for patients and for prescribers to prescribe them.

I think the other side, too, is patient knowledge. Look it up. I mean, to be fair, there’s a lot of misinformation out there. So I would say, doctors will know the best patient advocacy groups and different medical groups, they’ll know where to find accurate information about biologics and the biosimilars. And so, ask for more information. There’s nothing wrong with being more informed – as long as you and your doctor are having a conversation, you can say, ‘I saw this – can you tell me more about it?’

Conner:  So Zoe, is the confusion because biosimilars have only been around for a few years here in the U.S.?

Zoe: Not entirely. Dr. Simon Helfgott is a Boston-area rheumatologist. He told me that prescribers sometimes don’t spell out the distinction between a biologic and a biosimilar because there’s fundamentally no difference between the two. But he said that needs to change.

Helfgott: What I try to tell patients is when we are selecting a biological drug, it’s usually a talk about the concepts of the drug we’re going to use, why it might be the drug of choice for that particular patient, what its benefits are and what the side effects may be. I’m not going to distinguish whether they’re going to get the brand name or the biosimilar because really, it’s been shown that these are virtually identical. So it’s not as though I would say to them, ‘If you happen to get the biosimilar drug for this product, it’s going to be a lot different, and these things will happen. But if you get the brand name, these things will happen.’ It really is the same conversation. So when you discuss this with patients, though, I think what we do need to change is up until now, most prescribers would just say ‘You’re going to get this drug,’ and we’d name the brand product. But there will be some confusion because I’ve had patients call me and say I thought you were giving me Inflectra and you gave me another name, or you’re giving me some other form of Infliximab  that I’ve never heard of. So I think it’s going to be incumbent on prescribers to explain that to patients that even though we’re using a one particular name, there are several options in that category. And for the most part, they should be viewed pretty much similar in terms of efficacy and tolerability.

Zoe: Still, it varies from prescriber to prescriber. I also spoke with Lauren McClinton from Toronto. She was diagnosed with juvenile idiopathic arthritis when she was just three years old, and she switched to a biosimilar after her other medication stopped working. She says although she did her research on her own, her rheumatologist also gave her a lot of good information.

Lauren: In my research online, at first I had sort of been wary of biosimilars, because they kind of felt like a generic or a not so great option. But after having a conversation with my rheumatologist, she explained that the biosimilar that I would be taking is very, very similar to the original one, and the difference really lies more so in the kind of the branding and the naming of it as opposed to the actual efficacy of the medication. My experience learning about biosimilars was just like, this is a great option that I think will work for you from a medical professional that I really trusted. And learning that it was man issue in regards to what would be covered under my insurance and less of a concern in regards to how well it would help me.

Zoe: And then there was Shelley Fritz, who was diagnosed with rheumatoid arthritis and fibromyalgia. She found out a few years ago that she could only get a biosimilar for her treatment in her area.

Zoe: Can you talk to us a little bit about what that was like and, and being faced with this option?

Shelley: At first it was, honestly it was very disappointing, because I had changed treatment six times. So I felt like a failure. But I needed to be done because the medicine that I was on, though it had worked fairly well for a few years and kept me working and doing the things that I needed to do, it wasn’t working as well as it had in the past, and I was still having a lot of issues with a lot of joint pain and fatigue and everything and, and stiffness that just wasn’t going away during the day. So my doctor and I talked about it and he said, what about changing to something else, like maybe a medicine that’s a TNF alpha blocker that I had tried before? Not that same medication, but I had tried something else in that classification. And I said, ‘Well, I don’t think that’s gonna work, because I’ve already tried that drug classification.’ Like I had this notion that I’ve already been there and done that. So now that I’ve moved on to other medicines and other classifications, I shouldn’t go backwards. But he explained to me that medicines do different things. And that although Remicade was a medicine that he was suggesting for me that wasn’t available in my area and the biosimilar for it – Inflectra – was available for me. So then I went down the rabbit hole of research, and I started looking up studies about Inflectra versus Remicade. And what was the level of efficacy between people who were just on, on Remicade, or ones who had switched to the biosimilars. And I was very pleased. I was a non-believer. So it’s just kind of getting familiar with what the biosimilar can do and, and go in there and look at the studies and see, did it make a big difference between being on the biosimilar or being on the compared medication?

Conner: So the bottom line here: don’t be afraid to do a lot of your own research when you’re thinking about switching to a biosimilar.

Zoe: Right. And Criswell Lavery, who I spoke with earlier, says your doctor can be your ally.

Lavery: Most doctors, if you say, ‘I would like to know more about this,’ they’ll do the research. You are their patient, they want to make sure that you are happy that you are healthy, and that you are getting the care that you need.  And so I don’t think there’s anything wrong with asking for more information about something that you’re unsure about. And I think that doctor/patient relationship and the communication is so, so important with things like this.

Zoe: Next time on ‘Breaking Down Biosimilars,’ we’ll hear more first-hand stories from people who’ve made the switch to a biosimilar.

Sabina Netto: All my inflammatory markers are down. The stiffness in the morning overall pain is significantly decreased. I feel significantly better, but the condition is still very much a daily part of my life and how I manage my energy and how I have to manage pain. It’s just a lot easier to manage.

Conner: And we’ll hear some helpful advice about getting more comfortable taking a biosimilar.

Zoe: We hope this episode helps you have more informed conversations with your doctor when discussing your treatment plan. We’d love to hear your feedback, so send your email to [email protected].

Conner: Thanks for listening to Breaking Down Biosimilars- a podcast that brings light to biosimilars and helps you better understand the role they play in your healthcare, now and in the future. If you liked this episode, give us a rating and write a review Apple Podcasts. It’ll help more people like you find us. I’m Conner Mertens.

Zoe: And I’m Zoe Rothblatt. See ya next time.

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

Shelley Fritz: I can turn faucets easier … get in to get a shower a lot easier … picking things up off the floor is just a little bit easier, which were much more difficult before I started on the biosimilar.

Zoe: Welcome to Breaking Down Biosimilars – a podcast that sheds light on biosimilars, and helps you better understand the role they play in your healthcare, now and in the future. I’m Zoe Rothblatt.

Conner: And I’m Conner Mertens. Both of us are Patient Advocates and Community Outreach Managers at GHLF. Our goal is to introduce you to biosimilars: what they are, how they get approved, their potential savings, and what promise they hold.

Zoe: We also hear from a few people who’ve been taking biosimilars about their own experiences. And we cover some of the common myths about biosimilars, and try to separate fact from fiction.

Conner: So in our first few episodes, we looked at what biosimilars are, how they differ from generic drugs, and how they get approved.

Zoe: We also talked about how biosimilars are relatively new to the U.S. market, and why patients are often reluctant to switch to a biosimilar until they learn more about them.

Conner: This time, we’re going to talk to several patients who’ve made the switch, and hear what their experiences have been like so far.

Zoe: Right. And the first thing to mention is that biosimilar drugs are administered in different ways, depending on the type of medication. But it will still be given the same way as its originator biologic. Some patients, like Shelley Fritz, travel to an infusion center to receive their biosimilar through an IV drip over several hours. Shelley takes the biosimilar Inflectra for her rheumatoid arthritis and fibromyalgia.

Shelley: My doctor was right on top of getting things submitted to insurance to get it approved. That can be a big holdup, and it has been a big holdup for me in the past. Then we set up an appointment for me to go to the infusion center, which is at my local hospital. And then I have a scheduled day to go. And this infusion is every eight weeks.

Zoe: What do you kind of do to keep yourself busy during that time?

Shelly: When you get there, the nurse will assess your vitals. And then they insert an IV. For some of us patients, we’ve had that done so many times that we don’t even feel it much anymore. And then I get all set up with all my things, like I brought my laptop a couple of times, thinking I might get some work done. And I’ll be honest, here’s what happens. The nurse gave me a heavy dose of Benadryl. And it makes me really tired. So I’d get all set up with all my things and then just fall asleep. So pretty much I’ve just decided over the years that the best thing to do is call this “me” time, and I really enjoy it. I actually enjoy my infusion day because it’s the day I bring the book I’ve been waiting to read. If I don’t get to it, I don’t get to, it’s not a big deal. I just kind of take that time for me and I just enjoy watching a favorite show or whatever. And then just go off to sleep, enjoy the day, feel a little rested when I’m done.

Zoe: And I love that you made this your you time and any activity that you can sit and relax and do is just something that you can bring to your infusion and make it a little bit happier and a little bit of a distraction. It’s great to hear that getting a biosimilar is pretty easy. It seems you got the needle put in and, and once you get over the insurance hurdles, then it’s pretty simple. You go, you get the needle put in, you relax as much as you can and you go home and you’re good the next day.

Shelly: Exactly. And then I don’t have to go back for eight weeks. It’s something I kind of look forward to anyway. I know that it’s going to help me because it’s kind of another sign that it might be working, because about a week before I’m scheduled to get my next infusion, I start feeling worse, much worse. So by the time that rolls around and I’m ready for infusion day, I know that it’s going to make me feel better, and it does. I can turn faucets easier … get in to get a shower a lot easier … picking things up off the floor is just a little bit easier, which were much more difficult before I started on the biosimilar.

Conner: So that’s what some patients have to do – travel to an infusion site to receive their biosimilar. Other patients, like Lauren McClinton, self-administer their medication at home with an injector pen. Here in the U.S. we don’t have injectable biosimilars yet, they are expected in the next few years. Lauren is in Canada so she has this availability. Lauren is diagnosed with juvenile idiopathic arthritis.

Lauren: I had worked myself up to feeling like an injection was a really, really big deal, and it can be a really big deal. But it really most of the time does just feel like a pinch. I’d say it’s like less than a four on the pain scale for maybe like seven seconds most. I love that everybody has   different things that they do to make their injection experience easier. And I used to be super, super needle-phobic. And I used to be very scared of doing an injection on my stomach or my tummy. But I find now that it’s the best place to do it. I almost always do my injections in the evenings. It’s a very small little injector pen, which is super-handy.

Zoe: Well, that’s a good trade-off compared to the pain of the arthritis.

Lauren: I would much rather take seven seconds of like a little bit of ouching, followed usually by a chocolate bar, than a whole week of feeling really tired with achy joints and soreness getting in the way of other stuff that I want to do.

Zoe: And a chocolate bar is a terrific end to the injection.

Lauren: Absolutely. Being able to take it just once a week in this tiny little injector pen is fantastic. It feels great to be able to have it sort of just on hand. The whole process from start to end takes like 15 minutes. I think it’s easy to think about a medication like this as a really invasive or sort of looming medical option. I definitely, before I started it, it felt like a really big deal. I would say that it’s the medication that has worked most easily into my life in my routine. Because it’s so easy to manage. And because you take it once, it’s easy to do. And then I feel great for a week.

Conner: Lauren receives her medication through a nearby specialty pharmacy, and she says they’re very efficient – still delivering to her house even after she moved 45 minutes away.

Lauren: They call me when they’re about to be outside and I run downstairs and I receive my big refrigerated package of the biosimilar. And then it goes right in my fridge. And often, because they are very on top of it – they manage all of the insurance and provincial coverage of the biosimilar – some days, I’ll get a call, and I won’t even realize that I’ve been low on the medication, and they’re here with more. At the beginning, I probably would not have said that it’s such an easy process, because getting it set up is a different animal entirely. But having it delivered is fantastic and so easy.

Zoe: How are you feeling now, one year into being on this biosimilar? How has it helped you? In what ways do you feel better … maybe not so much? Tell us about how you’re doing.

Lauren: The number one greatest impact that is had has been helping manage my fatigue. Before taking a biosimilar I was able to curb my joint pain and symptoms like that through other types of medication. But I never really found that anything    really was able to tackle the fatigue, and it’s not something that you notice because fatigue sort of sneaks up on you and you don’t really notice that you’re feeling tired every day until you’re not tired every day. And that was really, really stupendous. So being able to wake up in the morning and actually feel like I slept the night before was amazing. And being able to get through a week or two weeks without feeling like, well because I did something at the beginning of this week. I can’t do something at the end of this week also. Or really having to carefully budget my time and energy, I think that taking a biosimilar has massively helped those feelings.

Zoe: So Lauren’s experience with taking a biosimilar has been a success so far. Shelley Fritz, who we met earlier, also faces the daily challenge of managing her fatigue.

Shelley: Like worse-than-ever fatigue. Like I can’t even imagine a time in my life that I’d been teaching full time. Now I’m retired from teaching, so I’m having fatigue now that I never had before.

Zoe: Shelley says being up front with her doctor about how she was feeling allowed them to jointly decide on a treatment option.

Shelley: He’s upping the dosage of my biosimilar for my next appointment. So there are things that can be done and new medications out there that your doctor might suggest for you. If you just tell your doctor what’s going on and what your goals are to feel better.

Zoe: I also spoke with Sabina Netto, who takes Inflectra to treat her psoriatic arthritis. Sabina shared some interesting analogies which describe how fatigue affects her daily life. One of them is the Spoon Theory that was created by Christine M. Christine lives with lupus, and uses this theory to explain to a friend the realities of living with chronic illness.

Sabina: In any given day, you have a certain number of spoons. Let’s just say it’s 50 spoons. And so that’s your energy reserve. So let’s say taking a shower, blow-drying your hair, getting ready in the morning takes 10 spoons or five spoons or two spoons. Making breakfast takes a certain amount of spoons, driving to work. So you have these set number of spoons and you learn how many spoons different activities take. So you know if 30 is your max, before you are kaput, then you know, okay, so if I have to go grocery shopping today, maybe that’s not the day I do the full curly-hair method at home in the morning because I know that, wash, diffuse all that stuff is gonna take forever and a lot of spoons. And so maybe I don’t do those two things on the same day. The other analogy I use, I had to get a new iPhone recently because my old iPhone, I’ve had for a long time. And you would leave the house and it was a hundred percent. And by the time I got to my destination, it was like 30%. And, it really made me think about – it reminds me of me. How you leave the house with your fully charged battery, you know it’s going to last you all day. But like when you have an auto-immune condition, you leave the door at 100 or you never really at a hundred, you can leave the door to 80. And then by the time you’re done grocery shopping, you’re at 20, you need to plug it in, rest and charge. And so that’s just another analogy that was kind of funny.

Zoe: Given the two analogies, the spoons, charging, do you think that your biosimilar has helped maybe add some spoons to your day or increase your charge?

Sabina: One hundred percent. All my inflammatory markers are down. The stiffness in the morning overall pain is significantly decreased. I feel significantly better, but the condition is still very much a daily part of my life and how I manage my energy and how I have to manage pain. It’s just a lot easier to manage. I think that now, because you’re not spending so much of your energy in pain, when you just want to make breakfast or you wanna cut up a vegetable, how much energy you put into, it hurts, but I still want to do it, and you don’t have to do that. So that part is diminished. I feel like you do get those energy stores back. And then in general, I think just because it is helping to improve your condition, that it, you know that some of the fatigue is diminished. So I don’t feel the level that deepness of fatigue, but I definitely get tired and I have to sit and rest and respect that.

Zoe: Next time on ‘Breaking Down Biosimilars,’ we hear about the insurance maze that patients often face when they switch from a biologic drug to a biosimilar. And we’ll look at why predictions of big savings with biosimilars have yet to come true.

Helfgott: We have a lot of patients who go for infusions, and we might write the order for one particular drug. And that may have been written six or eight months ago. And now that patient’s insurance has changed, or maybe it hasn’t even changed, the insurance company has changed their minds. And then suddenly, they’re saying, ‘The drug we gave you before is not on our formulary.’

Conner: We hope you learned something in this episode about what it’s like to take a biosimilar. And if you’re currently taking a biosimilar, we’d love to hear from you about your experience. Send your email to [email protected].

Zoe: Thanks for listening to Breaking Down Biosimilars – a podcast that sheds light on biosimilars, and helps you better understand the role they play in your healthcare, now and in the future. If you liked this episode, give us a rating and write a review on Apple Podcasts. It’ll help more people like you find us. I’m Zoe Rothblatt.

Conner: And I’m Conner Mertens. See ya next time.

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

Dr. Simon Helfgott: We have a lot of patients who go for infusions, and we might write the order for one particular drug. And that may have been written six or eight months ago. And now that patient’s insurance has changed, or maybe it hasn’t even changed, the insurance company has changed their minds. And then suddenly, they’re saying, ‘The drug we gave you before is not on our formulary.’

Zoe: Welcome to Breaking Down Biosimilars – a podcast that brings light to biosimilars, and helps you better understand the role they play in your healthcare, now and in the future. I’m Zoe Rothblatt.

Conner: And I’m Conner Mertens. Both of us are Patient Advocates and Community Outreach Managers at GHLF. Our goal is to introduce you to biosimilars: what are they, how they get approved, their potential savings, and what promise they hold.

Zoe: We also hear from a few people who’ve been taking biosimilars about their own experiences. And we cover some of the common myths about biosimilars, and try to separate fact from fiction.

Conner: So Zoe, in our first few episodes, we’ve learned about what biosimilars are, how they work, how they get approved, and how they’ve slowly begun appearing in the US market over the last 6 years or so.

Zoe: We’ve also heard heard from a number of people currently taking biosimilars for various conditions. And most have said their experiences so far have been positive.

Conner: Which is encouraging news. But this time we’re going to address the proverbial ‘elephant in the room,’ which is the cost savings that were supposed to be part of the deal.

Zoe: Right. Because despite all the initial promises about how biosimilar medications can significantly reduce prices for consumers, we have yet to see that really happening.

Conner: Alright, so let’s break it down and try to understand why that is, and who all the players are in this – there are a lot.

Zoe: Well, first of all, biologic drugs are among the most expensive medications in the US. So you’d think that biosimilars should cost way less than biologics, because they cost less to develop and test, like we talked about in Episode 1. Because the biologic serves as the reference, we already have the blueprint, and don’t need to repeat all of the trials that the biologic went through.

Conner: But they still don’t cost any less, though, do they?

Zoe: It’s complicated. They were introduced at a lower price point than their reference biologic, but we haven’t seen a much lower price to the patient like we have seen in the generic market. And that’s because it’s up to the insurance companies to decide whether to pass these savings on to consumers.

Conner:  And – let me guess again – they haven’t.

Zoe: Nope. And insurers often argue that these savings can be passed through to patients in other ways, like lower premiums – the fixed amount you pay for insurance each month. But, we’re seeing that co-pays, deductibles and premiums all keep rising, which means that patients aren’t getting the promised savings.

Conner: Okay, but to be fair, experts say that there hasn’t been enough time to analyze and determine what savings biosimilars can generate.

Zoe: Right.  There are a lot of factors at play and we hope insurers do what they promise and lower premiums.

Conner: Dr. Simon Helfgott is a rheumatologist at Brigham and Women’s Hospital in Boston. He says sometimes insurance companies will arbitrarily switch a patient over to a biosimilar medication – a decision patients might be unaware of. And cost considerations might not leave patients with much choice.

Helfgott: Most well-run infusion centers will check ahead of time if they want to get paid, obviously, that the patient has coverage. And they will be instructed by the insurance carrier as to what is considered the first-line choice, and what is considered a non-choice. We have a lot of patients who go for infusions, and we might write the order for one particular drug. And that may have been written six or eight months ago. And now that patient’s insurance has changed, or maybe it hasn’t even changed, the insurance company has changed their minds. And then suddenly, they’re saying the drug we gave you before is not on our formulary, we’ve replaced it with this drug, and this drug may be a biosimilar,

Zoe: And it’s not like the patient can just say, ‘Okay, I want to stay on my originally prescribed treatment, so I’ll just pay the $50 difference out of pocket.’

Conner: But hold up Zoe, we have another term here – formulary.

Zoe: Good catch!

Conner: A formulary is a list of medications covered by your health plan. So what Dr. Helfgott was saying is that in that scenario, the list of medications changed. And this is a big deal to many people with chronic disease, who pick their insurance plan based on what drugs are covered. Ok, back to Dr. Helfgott.

Helfgott: We’re talking about companies, insurance companies like Cigna, Aetna saying, we will cover this infusion and they may cost say, $5,000 if you are getting the brand product, it’s going to cost you $15,000. So I think most people will carefully assess that situation and conclude that no, I will take whatever they’re going to offer.

Conner: So Zoe, because we’re both patient advocates, this immediately gets me thinking, what options do patients have in a case like this?

Zoe: support programs from drug manufacturers play a huge role here. There are often co-pay assistance programs run by the manufacturer of a drug that help pay a certain amount of the cost that you are responsible for.

Conner: I often find these by typing the name of the medication online along with the key word copay assistance. And you can enroll online through the support program and get the information pretty quickly. Some of these assistance programs are offered like a secondary insurance with a group number and all that information, and some are offered as a debit card with a certain amount of money allowed for the calendar year.

Zoe: And it is also important to note that these are for people with private health insurance, not government-run plans like Medicare or Medicaid. In thinking about what other options a patient has in this situation. Dr. Helfgott says being aware and having the knowledge about your medication and financial responsibility is really important here.

Helfgott: I would tell patients, you should know what you’re getting, you should know which formulation because each of the infused branded products that have biosimilars, there’s more than one now. And you should know what the co-payment coverage might be, because it may vary. Even though it may be less expensive for your insurance plan, ou don’t want to be in a situation where your co-payments support is now rendered useless and that there’s nothing to cover that.

Conner: Dr. Helfgott brings up a good point. As patients we have to look at our out-of-pocket cost. So while certain formulary changes are done by insurance companies to maximize their profit, not being able to use a copay assistance card will cost you more money out of pocket. Still, Dr. Helfgott says market forces, i.e. competition, will ultimately benefit patients if their insurance companies pass the savings to them.

Helfgott: If you’re the only one in a certain class, and your drug can command a $50,000 charge, there’s nothing to stop you next year from saying, we have no competition, let’s go up to $75,000. And, and that’s been a strategy for many companies. And I can understand why if you can do it and get away with it, I suppose that’s what people do. But that’s not really good for our overall economic health. So what will happen now, with a biosimilar, there’s going to be a competitor. The competitor, in order to get in with the insurance company, is going to have to offer a better price. Better price usually means anywhere from 20 to 40% reduction compared to the original price. So there will be a discount. And the originator product might decide, well, we don’t want to go out of business. Because if you recall what happens on the generic pill side, once a generic comes out, the original product basically disappears, companies have given up. But in this situation, a company may not give up with their biological, but that’s fine. But if they want to remain competitive, they may have to lower their price by 40%. So I think there’s going to be a healthy stress, healthy competition on pricing here that we haven’t had until now.

Zoe: All these behind-the-scenes deal are not transparent for patients and the negotiated discounts historically have gone back to the insurance company not the patient. Dr. Helfgott says there are a lot of players in the mix determining how biosimilars are paid for, who pays, and who gets discounts.

Helfgott: Your insurance company also has somebody working on their behalf called the pharmacy benefit manager. 

Conner: Pharmacy benefit manager? I know about them all too well.

Zoe: They started to pop up around 30 years ago, and at first all they did was make sure that your benefits were up to date, and made sure that your health savings accounts were up to date.

Helfgott: And then about 10 or 15 years ago, one of these companies realized, ‘Oh, we could start procuring these biological drugs and get them available for patients.’ And, you know, they just took off and they became these giant companies. And the problem with pharmacy benefit managers is that they work for their own benefit. I mean, their name is accurate, they’re really for the pharmacy benefit, they’re not for the patient benefit, and not even for the insurance company benefit. I’ll give you an example: If you have a drug or biological drug that, let’s say, costs $1,000 an injection, the pharmacy benefit manager will have a carve out where they will go and say to, say, Cigna, ‘Okay, we will get that drug for you. You won’t pay $1,000, we’ll get a discount down to let’s say, $850.’ And Cigna may say, ‘Fine,’ Well, then they will turn to the drug manufacturer and say, ‘We will get you 10,000 patients on Cigna, but you will give it to us for $650.’ So Cigna, the, the biological company may say, ‘Well, we have no choice, we want this business.’ So they’re pocketing the difference between the 650 and 850. And that’s how these companies become very, very rich and powerful very, very quickly.

Conner: Roughly a year ago, infusion centers near Dr. Helfgott were rejecting biosimilars because they said there wasn’t enough discounts with the contracts they had.

Helfgott: Suddenly, about six months ago, everything changed overnight, and they suddenly said, from now on, all for certain products to products in particular, everything will be biosimilar. Until proven otherwise.

Conner: Pretty amazing how things can shift on a dime like that.

Zoe: It really is. I also spoke with Dr. Robert Popovian, Chief Science Policy Officer here at the Global Healthy Living Foundation. He says currently, the market share for biosimilars is around 10% compared with biologics. Market share means overall uptake of something. One reason the market share for biosimilars is so low is because of this thing called rebate contracting, also known as rebate walls.

Popovian: And they force physicians or patients to use, higher price alternatives that are there. Because the higher the price, the more rebates and fees are collected by insurers, and therefore it’s more profitable for them to use higher price medicines, than lower price alternatives such as biosimilars. And why have they been even more successful in the marketplace for autoimmune disorders than, let’s say, cancer or supportive care products? It’s because of the system we currently have, which is these are chronic diseases, that patients on, stay on for a very long time. And therefore, the rebating system is much more successful in those markets than a cancer therapy that is used for shorter periods of time.

Conner: Even so, Dr. Popovian sees the beginnings of a positive trend in the marketplace.

Popovian: Since the introductions of the biosimilars in the marketplace, the originator prices have dropped significantly. And despite not having a huge market share, there’s still price pressure that we see. So it’s important to continue this market as it is and continue introducing biosimilars into this market and continue pushing this market forward. Because if biosimilars withdraw and go out of that market, what will happen is that originator prices will keep going up. And we don’t want that.

Zoe: And there’s a bit more good news to report.

Conner: We all love good news, Zoe. Let’s hear it.

Zoe: Well, many biosimilar manufacturers are starting to get more aggressive with their pricing structures, offering their products at much larger discounts compared to their originator biologics…in one case, over 50% less.

Conner: That’s encouraging. And when you consider that generics at your local drugstore can cost up to 80% less than brand-name drugs, it makes sense that people want to see significant savings with biosimilars as well.

Zoe: Also, some large employers have begun negotiating with their insurers to have biosimilars placed in a lower co-pay tier than their biologics. And that’s helping to bring down costs for employees. One recent study found that participating companies saved 32% with the biosimilar infliximab compared with its reference biologic Remicade.

Conner: In these scenarios, the out of pocket cost for the patient will vary based on the health plan. But if there are these large savings in the overall price, there is potential to reduce the out of pocket cost for the patient.

Zoe: and reducing that cost is a huge deal for patients who live with chronic disease and are consistently burdened with the cost of paying for their medication at every refill.

Conner: Next time on ‘Breaking Down Biosimilars,’ we discuss some of the common myths and misinformation about biosimilars – and discover where the real truth lies, and what the medical facts actually tell us.

Helfgott: Patients will say to me, I don’t want a generic drug, you know, I have a hard time with generic drugs. And I tell them, this is not a generic. A biosimilar is a copy of the originator drug, but remember, the companies that are making the biosimilars are all huge bio-pharmaceutical companies themselves.

Zoe: We hope you learned something new in this episode. And if you’re currently taking a biosimilar, we’d love to hear about your own experience. Send us an email to [email protected].

Conner: Thanks for listening to Breaking Down Biosimilars – a podcast that sheds light on biosimilars, and helps you better understand the role they play in your healthcare, now and in the future. If you liked this episode, give us a rating and write a review Apple Podcasts. It’ll help more people like you find us. I’m Conner Mertens.

Zoe: And I’m Zoe Rothblatt. See ya next time.

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

Dr. Simon Helfgott: Patients will say to me, I don’t want a generic drug, you know, I have a hard time with generic drugs. And I tell them, this is not a generic. A biosimilar is a copy of the originator drug.

Zoe: Welcome to Breaking Down Biosimilars- a podcast that brings light to biosimilars, and helps you better understand the role they play in your healthcare, now and in the future. I’m Zoe Rothblatt,

Conner: And I’m Conner Mertens. Both of us are Patient Advocates and Community Outreach Managers at GHLF.

Conner: Our goal is to introduce you to biosimilars, what are they, how they get approved, their potential savings and what promise they hold.

Zoe: We also hear from a few people who’ve been taking biosimilars about their own experiences. And we cover some of the common myths about biosimilars, and try to separate fact from fiction.

Zoe: So Conner, we’ve talked a lot about how the adoption of biosimilars has been sluggish since they were introduced in the US in 2016 … even though it’s estimated that a strong biosimilar market could save the US as much as $54 billion over the next ten years.

Conner: So what’s stopping the market from flourishing?

Zoe: Well, skepticism, for one thing. It can be a long road filled with trial and error to find the right medication that works for you. So when patients find the right one, there’s a sense of loyalty to that medication, which you know is fair when you think about all that we as patients have to go through. And many people are convinced that if they’re already doing okay on their biologic medication, switching to a biosimilar could cause harmful side effects.

Conner: Well, something has to be fueling all that skepticism.

Zoe: What’s causing it is a lot of misinformation that began circulating when biosimilars first showed up. But the US Food & Drug Administration, or FDA, has begun cracking down. In February, 2020, they issued a joint statement with the Federal Trade Commission saying they intended to combat false or misleading statements about biosimilars.

Conner: Still, once misinformation begins to circulate, it can take a long time to counteract. So in this episode, we’re going to look at several common myths about biosimilars.

Zoe: And we’ll try to dispel those myths with the help of a few experts.

Zoe: Dr. Simon Helfgott has been a rheumatologist for 35 years. He’s he Director of Education and Fellowship Training at Brigham and Women’s Hospital in Boston. I asked him to explain some of the common myths about biosimilars.

Helfgott: One is, patients will say to me, I don’t want a generic drug, you know, I have a hard time with generic drugs. And I tell them, this is not a generic. A biosimilar is a copy of the originator drug. I think one of the concerns I had, and many rheumatologists I know had this many years ago, we were concerned that when biosimilars would come out, that would be made by these small companies overseas, in factories, that the FDA wouldn’t be able to inspect all the time, and that they might come in really cheap, but they might be dangerous, because the quality control would be lacking. That’s totally untrue. The companies that are making biosimilar products are companies that also make branded products. These are all the big players in biological drug manufacturing. So they all have the knowledge and the capability. So to me, it’s just a matter of, pick the one that you can get, that’s the best price and go with it. And I think that that’s the first myth I would like to de-bunk.

Conner: Dr. Helfgott also thinks there’s a lot of hesitancy among patients about transferability – or, switching to a biosimilar as a less costly alternative to a biologic.

Helfgott: I think there was concern again that, ‘Can I transfer after 10 years of being on this drug to that drug? Is there going to be any impediment, or toxicity or allergic reaction and so forth?’ And the answer is no, that does not appear to be any of that. I would use the analogy when the biologicals came out initially, we all had great excitement about their use, because they were so highly effective. But all of us were wondering, ‘Wait, something’s going to happen. You know, we’ve only used these drugs for one or two years, let’s wait five or 10 years and see what happens.’ Well, guess what, we now went to 20 plus years of using biological drugs. And there have really been no additional surprises. We know what the toxicities, what the risks are, but they really have not changed compared to what we knew 20 plus years ago. So I say the same thing will apply to biosimilars. We feel confident with their efficacy with their side effect profile, and with their benefits, and I don’t expect to see any surprises.

Zoe: And here’s another perspective. Dr. Robert Popovian is Chief Science Policy Officer here at the Global Healthy Living Foundation. He told me that many people are convinced that biosimilars won’t save money.

Popovian: That’s another misinformation that is out there that, oh, you’re not gonna save any money. They’re definitely less expensive. Even if you look at average sales price, which is as net price as you can get into this market. They are lower. Now we can argue what is lower, is it 10, 20, 30, 40% but they’re lower, you still have some cost savings. Even if they’re not lowering, like more than 20% or 10% than the originator biologic, their presence has created a dynamic in the marketplace and competitiveness that has lowered the price for everyone. So it is important to note that when biosimilars are introduced, they suppress prices for everyone not only for themselves, but also the competition that originated biologic prices keep coming down.

Conner: Dr. Popovian talks about a myth that’s cropped up only recently.

Popovian: A new one that’s been bandied about by certain folks incessantly for the last year and a half or two years or three years, is this this concept that biologics in general, are natural monopolies. And it’s absolutely not true. They’re wrong and they’re providing misinformation. Natural monopolies exist when you cannot create, basically, a competitive market. In the case of biologics, we have created a competitive market and competition through biosimilars. Now we can argue that biosimilar adoption has not been optimal in certain markets. But right now, formularies in the United States are built based on which drug gains the most rebates and fees rather than based on safety, efficacy and cost. Keep that in mind. Think about it. Formularies that we’ve been told by insurers and PBMs to be based on cost-effectiveness are not based on cost-effectiveness. They’re based on how much rebates and fees they collect, we need to get away from that. And that’s where these folks that keep incessantly talking about ‘biologics being natural monopolies’ and ‘we need to do price controls’ are dead wrong, and they’re missing the mark. If you want to fix it, fix the market.

Zoe: So Conner, we’ve heard about four myths today. The first – biosimilar quality control is lacking. The second – switching to a biosimilar from the biologic will lead to a bad reaction. The third – biosimilars don’t save money. And finally – biologics are monopolies and we cannot create competition.

Conner: and these are very real concerns. Especially for patients, who just want to feel good. So I hope we’ve helped everyone out there gain a bit of clarity on the truth, so they can make more informed decisions about their treatment plan.

Zoe: Me too, and given that biosimilars are still so new here in the U.S., hearing from experts like Dr. helfgott and Dr. popvian is reassuring to me.

Zoe: On our next episode of ‘Breaking Down Biosimilars,’ we’ll discuss the outlook for the next few years, as new biosimilar medications are approved and introduced into the US market.

Helfgott: The quality and the efficacy is all equal. The one remaining variable is the cost. And I think now that you’re seeing more and more products getting FDA approval, you’re going to see much more pressure for these products to come on the market.

Conner: And we’ll explore how more choices in the marketplace may finally begin to bring down prices for biosimilars.

Zoe: We hope you learned something new about the myths – and realities – of biosimilars. And as always, we’d love to hear what you think. Send us an email at: [email protected].

Conner: Thanks for listening to Breaking Down Biosimilars – a podcast that brings light to biosimilars, and helps you better understand the role they play in your healthcare, now and in the future. If you liked this episode, give us a rating and write a review Apple Podcasts. It’ll help more people like you find us. I’m Conner Mertens.

Zoe: And I’m Zoe Rothblatt. See ya next time.

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”

Dr. Simon Helfgott: The quality and the efficacy is all equal. The one remaining variable is the cost. And I think now that you’re seeing more and more products getting FDA approval, you’re going to see much more pressure for these products to come on the market.

Zoe: Welcome to Breaking Down Biosimilars- a podcast that sheds light on biosimilars, and helps you better understand the role they play in your healthcare, now and in the future. I’m Zoe Rothblatt,

Conner: And I’m Conner Mertens. Both of us are Patient Advocates and Community Outreach Managers at GHLF. Our goal is to introduce you to biosimilars – what are they, how they get approved, their potential savings and the promise they hold.

Zoe: We also hear from a few people who’ve been taking biosimilars about their own experiences. And we cover some of the common myths about biosimilars, and try to separate fact from fiction.

Zoe: So Conner, based on what we’ve learned so far, I think it’s safe to say that the US rollout of biosimilars over the last 6 years has been kinda rocky, to say the least.

Conner: Totally. And in our previous episodes, we talked about some of the reasons for why that is … one being the issue of all those cost savings we were supposed to see. But they haven’t really materialized, have they?

Zoe: Certainly not to any large degree. And you’d think they would, considering that biosimilars are less expensive to manufacture. And the process of getting them approved with the US Food and Drug Administration is a bit less rigorous than for biologics.

Conner: Yeah, on the surface, it doesn’t make a whole lot of sense. We also looked at other complicating factors, like rebate walls, the role of pharmacy benefit managers, and how insurance coverage can be unpredictable and arbitrary when it comes to biosimilars.

Zoe: Then there’s the uphill battle against all the misinformation that’s out there.

Conner: Right … biosimilars don’t work, they won’t be any less expensive, they’ll cause serious side effects …

Zoe: So, kind of a rough start all around. But Conner, take heart. There ARE a few things to cheer about looking down the road.

Conner: Yes! You know, at this point, we need a little cheering up!

Zoe: The first thing is that, starting in 2023, you’re going to see a bunch of new biosimilars coming onto the market … and hopefully that will begin to spur more competition.

Conner: And – can I be the eternal optimist here? – that should also lead to lower prices?

Zoe: It definitely should. These new medications have already been approved by the FDA. They include six new biosimilars for the biologic drug known as Humira – by six different manufacturers no less! These biosimilars will treat conditions like rheumatoid arthritis, Crohn’s disease, ulcerative colitis and others. Two other new biosimilars are also on the way for the biologic drug Enbrel, but those are still a few years away.

Conner: That is good news. But I’m curious about what the medical professionals think – whether they share the optimism.

Zoe: I think they do. We’ve heard a lot during this podcast series from Dr. Simon Helfgott. He’s the Director of Education and Fellowship Training at Brigham and Women’s Hospital in Boston. Dr. Helfgott says right now, we’re at a crossroads.

Helfgott: I think what we’re seeing now is a critical mass. And I think that in the next three to five years, we’re going to see a deluge because all the self-injectable drugs that are kind of waiting to come on the market will finally be able to do that because some of the patents of some of the popular biological drugs are coming off patent in the next 12 to 18 months. I think it’s just sheer number of biosimilars, we’ll get everybody across and break that barrier.

Conner: According to Dr. Helfgott, pricing is still a major issue, but one that can be overcome.

Helfgott: I think if we can figure out a way to moderate the cost of these drugs, while providing access to the drugs, and also hopefully with biosimilars insurance companies perhaps may not be as rigid, denying patients the way they sometimes do, most legitimate large insurance companies have policies in place to allow our patients access to these drugs, but I can tell you from experience since so many of our diseases are orphan diseases. There really may not be any FDA guidance for the use of biologics and some conditions, and we can have a tough time getting approval. But my hope is that with biosimilars keeping the cost down, we might be able to bend attitudes at the insurance companies and perhaps in the next couple of years, we’ll see some loosening in terms of criteria for us to access it in those situations where it’s been a challenge to get these drugs.

Zoe: Another doctor we’ve heard on ‘Breaking Down Biosimilars’ is Robert Popovian, a colleague of ours who’s Chief Science Policy Officer here at the Global Healthy Living Foundation. He shares Dr. Helfgott’s enthusiasm about the upcoming release of new biosimilars.

Popovian: I think it’s going to be better for access because we’ve seen that whenever biosimilars are introduced, the utilization actually went up. So it was basically patients who were not getting the biologic because of cost reasons that had more access to it, I think what you’re going to see in the US market is perhaps the adoption of biologics earlier on in the disease process, rather than having to go through other alternatives if the prices keep coming down, because they’re no longer going to be blocked by these prior authorizations. Which is also important, because we know that earlier, you treat the disease more aggressively with therapies, the long term, patients do better, there’s less instability, especially in autoimmune disorders, and less chances of being disabled because of their arthritis and everything else. I think we have a great opportunity here in the US market to really lower prices for everyone.

Conner: And even as medical professionals applaud the expanded choices that will soon be available, patients like Lauren McClinton from Ontario, Canada, say they’re already seeing the benefits.

Lauren: Having more treatment options, of course, has been a massively helpful and encouraging thing. It’s really, really nice to be able to look at all of the possible medication options that exist, so that I know that if things with the current biosimilar that I’m taking ever don’t work out, or it turns out it’s not right for me, I know that there are many, many options. I think it’s really amazing to have so many different treatment options, especially treatment options that are more accessible financially to everybody.

Conner: Thanks for listening to Breaking Down Biosimilars – a podcast that sheds light on biosimilars, and helps you better understand the role they play in your healthcare, now and in the future.

Zoe: We hope you learned something useful in this episode as we’ve looked ahead to what the future holds. And as always, we’d love to hear your thoughts about how the market for biosimilars may improve in the months and years ahead. Send us an email at: [email protected].

Conner: And if you liked this episode, give us a rating and write a review at Apple Podcasts. It’ll help more people like you find us. I’m Conner Mertens.

Zoe: And I’m Zoe Rothblatt.

“Be inspired, supported, and empowered, this is the Global Healthy Living Podcast Network.”