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Considerations in Demonstrating Interchangeability With a Reference Product	Draft Guidance	Draft guidance describing considerations for designating biosimilar biological products as interchangeable to a reference product.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Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products	Draft Guidance	Revised draft guidance on formal meetings between FDA and sponsors.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