Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products. BsUFA must be reauthorized every five years, and in September 2022, the President signed into law the third reauthorization of BsUFA, which establishes the program through fiscal year 2027.
To provide a snapshot of how FDA is meeting some of its BsUFA commitments, the following tables present a listing of required and completed deliverables. Many of these deliverables can be found elsewhere on FDA’s website but have been consolidated here for ease of access.
Please note:
- The tables focus on external activities or deliverables such as guidances, public meetings, public workshops, and updates or documents posted to the FDA website.
- The tables include the original deliverables FDA produced to meet its commitments, but they do not necessarily include more recent versions that may have posted after the deliverables were met.
- For more detailed and complete information regarding BsUFA performance progress, please see the BsUFA Annual Performance Report page.
Recurring Commitments
This table includes commitments that require regular updates (e.g., annually, quarterly).
Other Commitments
This table includes other commitments, that do not have a regular update (e.g., guidances, public meetings).
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Content current as of:
10/04/2024
