February 13, 2012

GHLF Applauds FDA Draft Rules for Biosimilars

Washington, DC – The Global Health Living Foundation, a member of the Alliance for Safe Biologic Medicines, welcomes the Food and Drug Administration's long-awaited draft guidance of the approval of biosimilars medicines.

The Global Healthy Living Foundation has been engaged with the FDA for over a year, and this pathway suitably reflects our initial concerns,” statedGlobal Healthy Living Foundation President Seth Ginsberg. “There is much that can go wrong if we ignore or underestimate the unique and complicated characteristics of biologic and biosimilar medicines. We encourage the FDA to continue to protect patients with measures that reflect their inherent challenges and look forward to continuing our dialogue with the Agency.”

The Global Healthy Living Foundation, a member of the Alliance for Safe Biologic Medicines, supports the following principles that would protect patients' safety and choice:

  • Measures that ensures biosimilars are as safe as their biologic reference products;
  • No substitution between biosimilars and the reference product without prior consent of patients and their doctors;
  • Clear labels, names and other marketing measures that enable patients, physicians and government agencies to differentiate between all medical products;
  • And a robust pharmacovigilence system to track and trace molecules to their origin by manufacturer and batch to protect patients should something go wrong.

GHLF will continue working to ensure patients maintain access to safe and effective medicines, regardless of cost.

Contact: Seth Ginsberg, GHLF President
Call (845) 348-0400
Or click here to send an e-mail through the website
Download the official press release (PDF: 212 KB)