For Industry

Biosimilar User Fee Act (BsUFA)

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  • FY18 BsUFA Fees

    BPD Initial $ 227,213
    Annual $ 227,213
    Reactivation $ 454,426
    Application w/Clinical Data $ 1,746,745
    w/o Clinical Data $ 873,373
    Program $ 304,162
  • On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of BsUFA through September 2022.
  • 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 CDERCollections@fda.hhs.gov. 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 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.

 

 

Page Last Updated: 09/18/2017
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