BsUFA talks progress on supplements, meetings and guidance development
In the latest round of negotiations between the US Food and Drug Administration (FDA) and the pharmaceutical industry on the reauthorization of the Biosimilar User Fee Amendments (BsUFA), the two sides reached common ground on several topics, including supplements and labeling for product safety updates, meeting management and application review practices.FDA and industry began negotiations on the third BsUFA program in March following a public kickoff meeting last November. (RELATED: FDA, Industry set priorities for BsUFA III, Regulatory Focus 19 November 2020; FDA, industry make opening bids in BsUFA III negotiations, Regulatory Focus 29 April 2021).
During the 4 May meeting, FDA went over refined language on supplement categories and timelines. “Industry generally agreed to the categories and timelines and requested that FDA provide draft commitment letter language and a resource estimate,” the minutes read. Industry also proposed timelines for product safety labeling updates, which FDA agreed to consider. The following week, on 11 May, FDA and industry once again agreed on revised language on supplement categories and timelines, and FDA said it would propose its resource needs for supplement reviews at a subsequent meeting. (RELATED: BsUFA III negotiations turn to supplements, technology proposals, Regulatory Focus 26 May 2021).
Meeting management was also discussed on both days, with industry and FDA in general agreement on the format and timing of a new type of biological product development (BPD) meeting aimed at providing industry with more targeted feedback. During the 11 May meeting, the two sides hammered out their differences on proposed changes to Type 4 meetings and began working on meeting management metrics to collect and report in BsUFA III.
Guidance development was also on the agenda for both sessions. With biosimilar interchangeability a top guidance priority for industry, FDA made a proposal to support scientific research and guidance development on the topic as part of its BsUFA III program. Industry in turn said it would consider FDA’s proposed approach and FDA committed to charting out a timeline for key guidance deliverables.
After hearing FDA’s updated proposal for best practices during application review, industry groups signaled support for the changes and the two sides held discussion on continued follow-up on the implementation of best practices.
During the 11 May meeting, FDA presented its proposed BsUFA III regulatory science pilot program, which industry said it would support “with defined research topics and deliverables.” Industry said it would also get back to FDA with topics of interest for research under the program and asked how FDA intended to scale the pilot. (RELATED: BsUFA talks continue on technology, regulatory science and reviews, Regulatory Focus 4 May 2021).
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