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

  • 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.
  • Starting fiscal year (FY) 2021, FDA will no longer permit the transferring of application fee payments from a previous FY cover sheet to a current FY cover sheet. Instead, payments from previous FY cover sheets without a corresponding application submission will only be processed as refunds to the original payors.  To ensure your refund Form FDA 3913 should be completed and submitted to CDERCollections@fda.hhs.gov and cc: userfees@fda.hhs.gov.  Applicants will have to submit a new user fee cover sheet with new payments for their application submission for the new fiscal year.  For more information, please see the BsUFA cover sheet FAQs.   
  • Fiscal Year (FY) 2021 BPD/Program Fee invoices were emailed on August 21, 2020.  Full payment of the invoice is due on October 1, 2020.  If you do not receive your invoice by August 24, 2020, please contact the BsUFA User Fee staff at CDERCollections@fda.hhs.gov.  
  • The BsUFA user fee rates for Fiscal Year (FY) 2021 was published in the Federal Register. Please see the table below for the FY 2020 and FY 2021 rates.
  • If you plan to discontinue participation in the BPD program prior to FY 2021, you must submit a formal written request to the regulatory project manager for the pre-IND or IND no later than  August 1, 2020, pursuant to section 744H (a)(1)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C §379j-52(a)(1)(C)). Please send a courtesy copy to CDERCollections@fda.hhs.gov.  Requests received after August 1st will result in the firm receiving an annual BPD invoice for FY 2021.
  • Completed BsUFA II Deliverables 

FY 2020 and FY 2021 User Fee Rates

User Fee Type FY 2020 FY 2021
Biosimilar Biological Product Development (BPD) Fee Initial BPD $ 117,987 $ 102,494
Annual BPD $ 117,987 $ 102,494
Reactivation $ 235,975 $ 204,988
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.



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