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  1. FDA User Fee Programs

Biosimilar User Fee Amendments

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  • In preparation for FDA’s annual FY 2023 BsUFA invoices, the Notification of Annual BsUFA Fees correspondence was emailed to sponsors in the BPD program and applicants subject to program fees on June 10, 2022. Please submit your response by June 24, 2022. If you have any questions, please contact us at [email protected].
  • If you plan to discontinue participation in the BPD program prior to FY 2023, you must submit a formal correspondence requesting to discontinue participation in the BPD program to the pre-IND file or withdraw the IND (with a statement to discontinue participation in the BPD program) no later than August 1, 2022, pursuant to section 744H (a)(1)(C) of the Federal Food, Drug and Cosmetic Act. Please send a courtesy copy to [email protected]. Requests received after August 1st will incur an annual BPD fee invoice for FY 2023.
  • 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 [email protected]. Please continue to contact the User Fee Helpdesk at [email protected] for technical assistance with assessing and completing the Biosimilar User Fee Coversheet.

FY 2021 and FY 2022 User Fee Rates

User Fee Type FY 2021 FY 2022
Biosimilar Biological Product Development (BPD) Fee Initial BPD $ 102,494 $ 57,184
Annual BPD $ 102,494 $ 57,184
Reactivation $ 204,988 $ 114,368
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 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. 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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