BioRationality: The FDA Sets Sights on Removing Clinical Efficacy Studies for Biosimilars
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Fifteen years have passed since the Biologics Price Competition and Innovation Act (BPCIA) transformed the biosimilar landscape. Today, we are at a crucial point: the FDA has finally removed clinical efficacy studies for all biosimilar molecules, marking the most significant regulatory change in biosimilars' history.
“we'll be releasing new draft guidance today to remove the comparative study requirement for biosimilar applications. It should shave off 3-4 years from the approval process.”
FDA Commissioner Marty Makary, MD, MPH, confirmed this on October 29, 2025, at GRxBiosims2025. This is the first time the FDA has announced a commitment to extending the waiver to all biosimilars.
Author's summary: FDA removes clinical efficacy studies for biosimilars.