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.
- Biosimilar User Fee Rates for Fiscal Year 2015
- Biosimilar User Fee Act of 2012 (Title IV of the Food and Drug Administration Safety and Innovation Act)
- Biosimilar Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017
FY16 BsUFA Fees
- 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.
- Federal Register Notice
Biosimilar User Fee Rates for Fiscal
- FDA User Fees 2012: How Innovation Helps Patients and Jobs
- Statement from HHS Secretary Kathleen Sebelius on the signing of the Food and Drug Administration Safety and Innovation Act
- User Fees: Ensuring a Stronger and Better FDA
Fact Sheet: New "Biosimilars" User Fees Will Enhance Americans' Access to Alternatives to Biologic Drugs
- FY 2014 Government Shutdown
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations