For Industry

Biosimilar User Fee Act (BsUFA)

Latest News:
  • The FDA User Fee System, which includes electronic payments through, will be unavailable from 12:00 AM EST on Friday, January 1, 2016, to 8:00 AM EST on Monday, January 11, 2016, due to maintenance activities. We regret any inconvenience during this routine maintenance and look forward to continuing successful operations in the new year.
  • The FY 2016 annual BsUFA invoices were emailed on Friday, August 14, 2015. Payment is due on October 1, 2015. If you did not receive an invoice, please contact the Biosimilar User Fee staff at 301-796-7900.

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.

FY16 BsUFA Fees

w/o Clinical$1,187,100


Page Last Updated: 12/30/2015
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