BioRationality: The FDA Sets Sights on Removing Clinical Efficacy Studies for Biosimilars
The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.
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“we'll be releasing new draft guidance today to remove the comparative study requirement for biosimilar applications.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.”
According to FDA Commissioner Marty Makary, MD, MPH, this change was announced at GRxBiosims2025 on October 29, 2025.
Author's summary: FDA removes clinical efficacy studies for biosimilars.
More News
- Sweet or scary: Which Halloween candies have the most sugar?
- Fiji Law Society Convention 2025
- Project Snapshot: 221-unit apartment project begins to rise on former Dominion site in the Fan - Richmond BizSense
- Fed cuts interest rates for 2nd time this year amid hiring slowdown
- Editorial: Movable bike barrier a good step for Richmond Bridge