Completed BsUFA II 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 August 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), that includes the reauthorization of BsUFA through fiscal year 2022. To provide a snapshot of how FDA is meeting its commitments, the following table provides a listing of completed deliverables required under BsUFA.
Please note the summary table does not include deliverables intended for internal use, including:
- Updates to internal policies and procedures,
- Program updates or pilot programs,
- Staff training requirements and
- Interim milestones (e.g. Federal Register notices).
For more detailed information regarding BsUFA performance progress, please see the BsUFA Performance Reports page.
|Deliverable Title||Type||Description||Reference||Date Published|
|Considerations in Demonstrating Interchangeability With a Reference Product||Draft Guidance||Draft guidance describing considerations for designating biosimilar biological products as interchangeable to a reference product.||Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway||1/18/2017|
|Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products||Draft Guidance||Revised draft guidance on formal meetings between FDA and sponsors.||Meeting Management Goals||6/5/2018|
|Best Practices for Communication Between IND Sponsors and FDA During Drug Development||Final Guidance||Updated guidance on best practices for communication between IND sponsors and FDA during drug development.||Meeting Management Goals||12/29/2017|
|Nonproprietary Naming of Biological Products||Final Guidance||Publish final guidance on the nonproprietary naming of biological products.||Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway||1/13/2017|
|Labeling for Biosimilar Products||Final Guidance||Publish final guidance on the labeling for biosimilar products.||Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway||7/19/2018|
|Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product||Final Guidance||Publish final guidance on the clinical pharmacology data necessary to support a demonstration of biosimilarity.||12/29/2016|
|Resource Capacity Planning & Modernized Time Reporting Implementation Plan||Implementation Plan||Implementation plan for FDA's approach to resource capacity planning and modernized time reporting.||Resource Capacity Planning and Modernized Time Reporting||3/30/2018|
|Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2018 Version, for BsUFA||Report||FDA's initial five-year financial plan which will be updated annually.||Financial Transparency and Efficiency||3/29/2018|
|BsUFA Quarterly Hiring Updates||Website Posting / Update||Quarterly hiring data to provide updates on the status of BsUFA-hired FTEs.||Set Clear Goals for Human Drug Review Program Hiring||Last Updated: 10/9/2018|
Revised draft guidance on good review management principles and practices.
|First Cycle Review Management||9/25/2018|
Publish draft guidance on the evaluation of analytical similarity for biosimilar products.
Draft: 09/22/2017Withdrawn: 06/21/2018