BsUFA III commitment letter details FDA, industry goals for biosimilars program

Regulatory NewsRegulatory News | 21 September 2021 |  By 

After months of negotiation with industry, the US Food and Drug Administration (FDA) has released the commitment letter for the third iteration of its Biosimilar User Fee Amendments (BsUFA III) program which will run from FY2023-2027.
FDA also announced on Tuesday that it will host a public meeting to discuss BsUFA's reauthorization and gather feedback on the proposed program on 2 November 2021.
"The performance and procedural goals and other commitments specified in this letter apply to aspects of the biosimilar biological product review program that are important for facilitating timely access to safe and effective biosimilar medicines for patients," the agency writes. "FDA is committed to meeting the performance goals specified in this letter, enhancing management of BsUFA resources, and ensuring BsUFA user fee resources are administered, allocated, and reported in an efficient and transparent manner."
The commitment letter and reauthorization meeting are both integral steps in the reauthorization process, and once FDA has considered public comments on its recommendations for the program and adjusted them as necessary, the agency will present its recommendations to Congress. The current BsUFA II program is set to expire in September 2022 and must be reauthorized by Congress prior to then in order to continue.
Industry recently had a chance to weigh in on the BsUFA II program earlier this year in comments on a third-party interim assessment commissioned by the agency. (RELATED: Biosimilars industry weighs in on BsUFA II interim assessment, Regulatory Focus 2 April 2021)
The commitment letter follows more than a dozen meetings with industry groups following the agency's November 2020 kickoff meeting. During those meetings, guidance on interchangeability, establishing a regulatory science program for biosimilars, supplements and meeting management emerged as topics of interest for both parties. (RELATED: FDA, Industry set priorities for BsUFA III, Regulatory Focus 19 November 2020; Groups seek clarity on interchangeability in BsUFA III, Regulatory Focus 23 December 2020; FDA, industry make opening bids in BsUFA III negotiations, Regulatory Focus 29 April 2021; Regulatory science pilot floated in BsUFA III negotiations, Regulatory Focus 15 June 2021)
The letter itself details FDA's commitments and goals for the five-year program, which broadly cover the agency's review goals for original and supplemental biologics license applications (BLAs), biosimilar and interchangeable meeting management, resource management, hiring and retention and information technology infrastructure.
One of the biggest changes FDA is proposing for BsUFA III is to create new supplement categories, timelines and performance goals, with reviews ranging from 3 to 10 months depending on the supplement. Supplements that do not contain new efficacy data, such as those that make safety labeling changes or that add or remove indications, would have shorter review timelines under the proposal.
Under BsUFA III, FDA is proposing to maintain its review goals for original and resubmitted biological product application submissions and has promised to review and act on original manufacturing supplements under the same timelines as it has committed to in FY2022. The agency's goals for acting on other original or resubmitted supplements have changed in line with the new supplement categories being proposed for BsUFA III.
FDA would also shake up its meeting offerings, with changes to the biosimilar initial advisory (BIA) meeting, a new Type 2a meeting and changes to the timing of Type 4 meeting background packages. For BIA meetings, FDA would no longer require the submission of preliminary comparative analytical data and the Type 2a meeting would focus on one or two narrower issues. FDA also explains that Type 2 meetings under BsUFA II would be considered Type 2b meetings under BsUFA III.
FDA also lays out plans for advancing the development of interchangeable biosimilars, which has been a major pain point for industry under previous iterations of the program. The agency only recently approved Mylan's Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product. FDA says it will conduct research under the proposed BsUFA III Regulatory Science Pilot Program, develop "foundational guidance" and host a stakeholder workshop on the development of interchangeable products. (RELATED: FDA approves Semglee as first biosimilar interchangeable insulin, Regulatory Focus 28 July 2021)
Additionally, the commitment letter also details FDA's plans to improve communications with sponsors and to issue guidance on the agency's thinking on the use of alternative tools for assessing manufacturing in light of the COVID-19 pandemic.
FDA, Federal Register Notice


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