U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. Performance Data
  4. FDA-TRACK: Agency-wide Program Performance
  5. FDA-TRACK: Biosimilar User Fee Act Procedural Responses
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Biosimilar User Fee Act Procedural Responses


Biosimilar Applications and Supplements

Procedural Notifications

Procedural Responses


The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

Download BsUFA Procedural Responses Dataset


  • * Performance is currently preliminary due to pending submissions.
  • ** New Performance Goal for BsUFA III (see Changes for this Goal, page 28).

Sign up to receive FDA-TRACK updates

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top