BioRationality: FDA Pridefully Declares 50th Biosimilar Approval

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.