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  1. FDA User Fee Programs

Completed BsUFA II Deliverables

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Considerations in Demonstrating Interchangeability With a Reference Product Draft Guidance  Draft guidance describing considerations for designating biosimilar biological products as interchangeable to a reference product.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Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Draft Guidance  Revised draft guidance on formal meetings between FDA and sponsors.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. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 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

Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications

Draft Guidance

Revised draft guidance on good review management principles and practices.

First Cycle Review Management 9/25/2018

Statistical Approaches to Evaluate Analytical Similarity

Draft Guidance

Publish draft guidance on the evaluation of analytical similarity for biosimilar products.

Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway

Draft: 09/22/2017

Withdrawn: 06/21/2018