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  1. FDA User Fee Programs

Biosimilar User Fee Amendments

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  • Fiscal Year (FY) 2022 BPD/Program Fee invoices were emailed on August 13, 2021. Full payment of the invoice(s) is due on October 1, 2021. If you do not receive your invoice by August 16, 2021, please contact the BsUFA User Fee staff at CDERCollections@fda.hhs.gov
  • On July 28, 2021, the Food and Drug Administration announced the Biosimilar User Fee Rates for Fiscal year 2022 in the Federal Register for fees assessed under the Federal Food, Drug, and Cosmetic Act. These fees apply to the period from October 1, 2021, through September 30, 2022. Please see the table below for Fiscal Year 2021 and Fiscal Year 2022 fee rates.
  • 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 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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