For Industry

Biosimilar User Fee Act (BsUFA)

Latest News:

  • The FY 2017 annual BsUFA invoices were emailed on August 12, 2016. Payment is due on October 3, 2016. If you did not receive your copy of the invoice, please contact the biosimilar staff at 301-796-7900.

FY17 BsUFA Fees

BPD Initial $203,810
Annual $203,810
Application w/Clinical $2,038,100
w/o Clinical $1,019,050
Supplement w/Clinical $1,019,050
Product $97,750
Establishment $512,200
Reactivation $407,620


The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through September 2017.  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.



Page Last Updated: 04/20/2017
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