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

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. This table represents the original deliverables that FDA produced to meet its commitments, but it does not necessarily include more recent versions that may have posted after the deliverables were met.

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
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
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: 10/18/2019
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
Considerations in Demonstrating Interchangeability With a Reference Product Final Guidance  Final guidance to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). (Draft guidance published 1/18/2017) Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 5/10/2019
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Draft Guidance Draft guidance describing the Agency's recommendations on the design and evaluation of comparative analytical studies. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 5/21/2019
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments Public Meeting Public meeting to invite comments on financial transparency and efficiency of the user fee acts. Enhancing Management of User Fee Resources 6/7/2019
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
Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2019 Update, for BsUFA Report 2019 update to FDA's five-year financial plan. Financial Transparency and Efficiency 5/31/2019
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 6/4/2018
FY2018 Human Drug User Fees Financial Management Evaluation Public Report Evaluation of PDUFA, BSUFA, and GDUFA program resource management during FY 2018. Enhancing Management of User Fee Resources 5/22/2019
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
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
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) Draft Guidance Publish draft guidance on the processes and further considerations related to post-approval manufacturing changes for biosimilar biological products. (See Q.1.20 in draft guidance.)  Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 12/11/2018
Nonproprietary Naming of Biological Products Final Guidance  Publish final guidance describing FDA's current thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include FDA-designated suffixes.  Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 1/12/2017
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
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: 09/21/2017 Withdrawn: 6/21/2018

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