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  5. Completed BsUFA III Deliverables
  1. Biosimilar User Fee Amendments

Completed BsUFA III Deliverables

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).

CommitmentTopicRecurrence
Publish Quarterly Hiring UpdatesSet Clear Goals for Human Drug Review Program HiringQuarterly
Develop and Update Data and Tech Modernization StrategyInformation Technology Goals  Annually
Electronic Submission Gateway (ESG) Website UpdateMonitor and Modernize ESGAnnually
Publish Five-Year Financial Plan and Annual UpdatesFinancial TransparencyAnnually 

Other Commitments

This table includes other commitments, that do not have a regular update (e.g., guidances, public meetings).

CommitmentTopicDate Published
Publish Capacity Planning Implementation PlanResource Capacity Planning Implementation3/29/2023
Conduct Public Meeting Financial Plan FY23Financial Transparency6/8/2023
Publish Draft Supplements GuidanceGuidance8/11/2023
Publish Revised Draft Guidance on Changes to Meeting ManagementGuidance, Clarity, and Transparency8/11/2023
Publish Draft Guidance on Labeling for Interchangeable BiosimilarsFoundational Guidance Development9/18/2023
Publish Draft Guidance on Alternative Tools to Assess Manufacturing FacilitiesInspections and Alternative Tools to Evaluate Facilities9/22/2023
Update Relevant Documents Regarding Best Practices in Communication with Sponsors & Update Relevant MAPPS and SOPPs on Communication with Sponsors Promoting Best Practices in Communication Between FDA and Sponsors 12/26/2023
Publish Capacity Planning Implementation Plan Updates FY24Resource Capacity Planning Implementation3/22/2024
Publish Revised Draft Guidance on Promotional Labeling and Advertising for Interchangeable BiosimilarsAdvancing Development of Interchangeable Biosimilar Biological Products    4/25/2024 
Publish Combo Products Guidance Related to URRAsAdvancing The Development of Biosimilar Biological Device Combination Products Regulated by CDER and CBER7/8/2024
Publish Draft Guidance on Post Approval Manufacturing ChangesAdvancing Development of Interchangeable Biosimilar Biological Products7/23/2024
BsUFA Type 2a Meetings and Formats Granted, FY2023-FY2024Meeting Management Goals3/31/2025
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