On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the second reauthorization of the Biosimilar User Fee Act (BsUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for biosimilar biological products. The current legislative authority for BsUFA III expires in September 2027. At that time, new legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal year to fund the process for reviewing biosimilar biological products.
Information related to FDA’s preparation for the fourth reauthorization of BsUFA will be hosted on this page as it becomes available.
BsUFA III Reauthorization Kickoff Public Meeting – December 3, 2025
The Food and Drug Administration is holding a public meeting on December 3, 2025 to kick off the process for reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028- 2032
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Content current as of:
11/03/2025
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