U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Biosimilar User Fee Amendments
  1. FDA User Fee Programs

Biosimilar User Fee Amendments

Latest News

  • The FY 2024 annual invoices for BPD and/or program fee(s) were emailed to sponsors in the BPD program and applicants with program-fee eligible biosimilar products on August 15, 2023. If you do not receive your invoice(s) by August 21, 2023, please contact the BsUFA User Fee staff at CDERCollections@fda.hhs.gov. Invoices are due by October 2, 2023.
  • The fiscal year (FY) 2024 BsUFA fee rates were published in the Federal Register (FR) on July 28, 2023. For more information regarding the FY 2024 fee rates, please see the FR notice available here.
  • FDA announces the publication of the final guidance for industry entitled Assessing User Fees Under the Biosimilar User Fee Amendments of 2022This guidance provides information to stakeholders regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2022 (BsUFA III) and changes created by the statute to definitions, to certain user fee exceptions, and to user fee policies and procedures.
  • 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.


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.

Sign up to receive email updates about the Biosimilar User Fee Act (BsUFA)

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top