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  1. FDA User Fee Programs

Biosimilar User Fee Amendments

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FY 2023 and FY 2024 User Fee Rates

User Fee Type FY 2023 FY 2024
Biosimilar Biological Product Development (BPD) Fee Initial BPD $ 47,325 $10,000
Annual BPD $ 47,325 $10,000
Reactivation $ 94,650 $20,000
Application Fee Clinical Data Required $ 1,746,745 $1,018,753
Clinical Data not Required $ 873,373 $509,377
Program Fee $ 304,162 $177,397

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 2022 through September 2027. FDA dedicates these fees to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public.

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