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Biosimilar User Fee Act (BsUFA)

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  • If you plan to discontinue participation in the BPD program, you must notify FDA (i.e., the regulatory project manager for the pre-IND or IND) by August 1, 2017, 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 Requests received after August 1st to discontinue participation in the BPD program may result in the firm receiving an annual BPD invoice for FY 2018 if BsUFA is reauthorized.

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: 07/25/2017
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