Biosimilar User Fee Act (BsUFA)

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 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