Patients for Biologics Safety & Access Sends letter to FDA expressing concerns About the FDA Advisory Committee Process for Biosimilars


In Letter to the FDA, Patient Advocates Cite Concerns About Lack of Experts on Advisory Committee Panels and Final Approval Standards for Biosimilars

May 06, 2015 – Patients for Biologics Safety & Access, a coalition of over 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics, today announced that they have sent a letter to the U.S. Food and Drug Administration (FDA) urging the Agency to include experts with institutional knowledge of the review criteria and process for biosimilars on forthcoming Advisory Committees and ensuring the Agency initiates notice-and-comment rulemaking on critical patient safety issues before approving any additional biosimilars.

“Currently, the FDA is structuring the Advisory Committees by therapeutic areas. The Oncologic Drugs Advisory Committee reviewed the first biosimilar application for filgrastim and the Arthritis Advisory Committee is scheduled to review the second biosimilar application for infliximab. This structure allows for no provision of adequate expertise in the biosimilar review standards and process. Each committee will be new to the review criteria and process for biosimilars. This leaves the Committees overly reliant on FDA for guidance on making its recommendations on the approval of biosimilars,” said Patients for Biologics Safety & Access in the letter.

Biologics are complex medicines that are made from living cells. “Biosimilars” are biologics that are similar, but not identical to, a previously approved biologic. Unlike generic versions of small-molecule drugs, there can never be identical versions of biologic drugs.

“Patient safety needs to be at the forefront as the FDA approves biosimilars. The FDA has finalized several guidance documents regarding biosimilars, but the Agency has yet to issue final guidance on crucial patient safety issues such as interchangeability standards, pharmacovigilance monitoring system and naming. Given the importance of this issue to patient safety, we are asking that you take the necessary steps to issue final approval standards and processes and ensure the Advisory Committee members have expertise with biologics,” the patient groups added in the letter. 

The full letter can be found here.