For Industry

Biosimilar User Fee Act (BsUFA)

Latest News:
  • In preparation for our annual FY 2017 BsUFA invoices, the “FY 2017 Notification of Annual BsUFA Fees” letter was emailed on Wednesday, June 1, 2016.  Please submit your response by Friday, July 8, 2016.  If you have any questions regarding the letter, please send an email to CDERCollections@fda.hhs.gov or call 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

BPD Initial $237,420
Annual $237,420
Application w/Clinical $2,374,200
w/o Clinical $1,187,100
Supplement w/Clinical $1,187,100
Product $114,450
Establishment $585,200
Reactivation $474,840

 

Page Last Updated: 06/13/2016
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