On August 18, 2017, the President signed into law the FDA Reauthorization Act of 2017 (FDARA). FDARA included amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to revise and extend the user fee program for biosimilar biological products, through the Biosimilar User Fee Act (BsUFA) reauthorization, known as BsUFA II. BsUFA II authorized FDA to assess and collect fees for biosimilar biological products from October 2017 to September 2022 (FY 2018 through FY 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.
BsUFA I and BsUFA II
Since the implementation of BsUFA in 2012, FDA has used BsUFA resources to expedite the process for the review of biosimilar biological product submissions, including applications, supplements, notifications, responses, and meeting management. Without the funds derived from BsUFA fees, the progress FDA has achieved in improving these processes would not have been possible.
- BsUFA I (FY 2013 to FY 2017). With increased resources under BsUFA I, FDA was able to begin development of the infrastructure needed to support the biosimilar review program and commit to review performance goals that incrementally increased to 90 percent levels over a 5-year period.
- BsUFA II (FY 2018 to FY 2022). BsUFA II focuses on ensuring effective scientific coordination and review consistency through review, procedural, and meeting performance enhancements. FDA’s commitments also include enhancing capacity for guidance development in specified areas and expanding review staff capacity and training.
Annual performance reports are prepared by FDA’s Office of Planning, Evaluation and Risk Management in collaboration with the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
For additional information on these reports, please contact:
Office of Planning, Evaluation and Risk Management
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002