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  1. FDA User Fee Programs

Biosimilar User Fee Amendments

Latest News

  • Beginning February 13, 2023, CDER and CBER will begin accepting meeting requests for in-person, face-to-face industry meetings (with a hybrid component), starting with Type A, BPD Type 1, and Type X meeting requests.
  • On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of the Biosimilar User Fee Act (BsUFA), known as BsUFA III. BsUFA III authorized FDA to assess and collect fees for biosimilar biological products from October 2022 through September 2027 (fiscal years 2023 through 2027).
  • The fiscal year (FY) 2023 BsUFA fee rates were published in the Federal Register (FR) on October 7, 2022. For more information regarding the FY 2023 fee rates, please see the FR notice available here.
  • CDER’s Work to Meet User Fee Goals During the Pandemic: This webpage will provide periodic updates on key user fee metrics related to application review and the pre-approval process throughout the COVID-19 pandemic.
  • IMPORTANT NOTICE REGARDING BIOSIMILAR USER FEE STAFF CONTACT INFORMATION: Due to the COVID-19 pandemic, and until further notice, electronic mail is the Biosimilar User Fee staff’s preferred method of receiving communication over postal mail.
  • If you have questions or documentation for the Biosimilar User Fee staff regarding BsUFA Fee requirements, waivers or refunds, please send them by electronic mail to CDERCollections@fda.hhs.gov. Please continue to contact the User Fee Helpdesk at userfees@fda.gov for technical assistance with assessing and completing the Biosimilar User Fee Coversheet.


FY 2022 and FY 2023 User Fee Rates

User Fee Type FY 2022 FY 2023
Biosimilar Biological Product Development (BPD) Fee Initial BPD $ 57,184     $ 47,325
Annual BPD $ 57,184 $ 47,325
Reactivation $ 114,368 $ 94,650
Application Fee Clinical Data Required $ 1,746,745 $ 1,746,745
Clinical Data not Required $ 873,373 $ 873,373
Program Fee $ 304,162 $ 304,162

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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