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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Biosimilar User Fee Act Procedural Notifications

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 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022. 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 Notifications Dataset


  • * Performance is currently preliminary due to pending submissions.
  • ** New Performance Goal for BsUFA II (see Changes for this Goal, page 14-15)
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