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BioRationality: FDA Pridefully Declares 50th Biosimilar Approval
Sarfaraz K. Niazi, PhD, congratulates the FDA on approving the 50th biosimilar, noting that there's more work to be done to expand the market.
Image credit: ink drop - stock.adobe.com
End of April 2024, the FDA made a significant announcement that it had approved 50 biosimilars 14 years after the Biologics Price Competition and Innovation Act (BPCIA) went into effect. While this is a hallmark moment, it remains an incomplete promise and hope related to biosimilars.
The FDA has approved biosimilars for only 15 molecules out of over 100 biologics that have had patents expired—and dozens more to join this list of candidates. The US-approved biosimilars are held mainly by big pharma companies as they can easily afford the cost of hundreds of millions of dollars for their approval.
However, the high development cost also means that biosimilars will remain high as these investments are amortized. The FDA can change the fate of biosimilars dramatically by adopting scientific rationality despite the misconstrued requirements listed in the BPCIA for biosimilar approval; the legislation gives the FDA that authority. Alas, some elements cannot be altered, such as the designation of interchangeable biosimilars, a classification that the US maintains with a few least-developed countries. There are legislative attempts to remove this despite the strong opposition by big pharma. So, until then, I believe the FDA should give interchangeable status to all first-time filers of a molecule—this will bring a deluge of new biosimilars.
Further, this approval should come without clinical efficacy testing that is now well-proven and redundant based on simple statistical calculations—no wonder these studies never fail because they cannot. The analytical assessment and clinical pharmacology profiling are more than enough to demonstrate the safety and efficacy of biosimilars. What is holding back is not any argument over the scientific merits of these suggestions but the conservative close-mindedness of the reviewers that is continuously instigated by the big pharma.
I wish to congratulate the FDA for reaching this milestone; I would be happier if the FDA had used this event to announce changes in the development requirements and become the leader in scientific pursuit.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
