Regulatory Focus™ > News Articles > 2021 > 4 > FDA, industry make opening bids in BsUFA III negotiations

FDA, industry make opening bids in BsUFA III negotiations

Posted 29 April 2021 | By Joanne S. Eglovitch 

FDA, industry make opening bids in BsUFA III negotiations

The US Food and Drug Administration says that meeting goals related to industry meetings “continues to be a challenge” in its negotiations with industry on the third iteration of the Biosimilar User Fee Act (BsUFA III) program for FY2023-27.
BsUFA, originally enacted in 2012, authorizes FDA to collect fees from biosimilar developers to help fund the agency’s review program. As with the agency’s other user fee programs, FDA and industry negotiate terms for the agreement and establish a set of performance goals and commitments for the five-year program.
FDA made this statement in a collection of meeting summaries from the first three meetings held with industry in March.
The meeting summaries, which were recently released, show the industry, represented by the Association for Accessible Medicines (AAM), Biotechnology Innovation Organization (BIO), Biosimilars Forum and PhRMA, and FDA discussing views on reauthorization, reviewing ground rules for negotiating in a virtual environment, and the agency’s proposals on categorizing supplements.
At the kickoff meeting for the reauthorization process for BsUFA, FDA and industry last year shared their wish lists for the third iteration of the agency’s biosimilars review program. (RELATED: FDA, industry set priorities for BsUFA III, Regulatory Focus, 19 November 2020).
The minutes from the 6 March meeting state that “the ground rules governing the BsUFA III reauthorization negotiations were reviewed and agreed upon by industry representatives and FDA.” At this meeting FDA discussed the overall experience to date in BsUFA I and II.
The summary states that “the agency highlighted that although biosimilar development program enrollment continues to grow, application submissions vary from year to year. FDA noted that while they generally met core review performance goals, meeting management continues to be a challenge. FDA explained that the flexible independent user fee structure established in BsUFA III has been effective in managing fluctuations in fee collection and maintaining predictable application and program fee amounts.”
A recent report issued by FDA’s Center for Drug Evaluation and Research has shown the center is missing more BsUFA target dates amid the pandemic. The report noted that original biosimilar product applications were acted on by BsUFA target date 75% of the time in the in the last quarter of FY 2020; in the first quarter of FY 21, CDER hit its target date for just 67% of these applications. (RELATED: CDER missing more BsUFA targets dates amid pandemic, Regulatory Focus, 17 March 2021).
FDA also presented its proposals for BsUFA III enhancements related to regulatory science, supplements, human factors protocols and use related risk analysis, information technology, inspections, and finance.
Industry participants raised a somewhat different set of issues, highlighting communication and meetings, supplement review, labeling, guidance development, inspections, information technology, and financial accountability and staffing as their top priorities for the upcoming BsUFA program. However, the PhRMA and BIO disagreed with a proposal presented by AAM and the Biosimilars Forum on regulatory science.
During the subsequent meeting on 23 March, industry called for FDA to issue guidance during BsUFA III on the use of alternative tools to assess manufacturing facilities in pending applications, which FDA tentatively agreed to do. Industry also proposed several changes to formal BsUFA meetings, including changing the description of biosimilar initial advisory (BIA) meetings, creating a new biosimilar biological product development (BPD) meeting for more focused questions and modifying the Type 4 meeting process.
At its last meeting on 30 March, participants discussed proposals related to supplements, product safety update labeling, guidance development and FDA’s five-year financial Plan for BsUFA II.
Industry said it would like to see FDA develop guidance on chemistry, manufacturing and controls (CMC) post-approval manufacturing changes and biosimilar interchangeability early on in BsUFA III, something FDA said it would look into.
FDA also presented their proposals on supplement categorization and review timelines and provided a rationale for their proposed timelines. Industry asked clarifying questions about the supplement categories proposed by FDA. FDA agreed to provide additional detail and examples in a follow-up meeting.
FDA noted “the difficulty of assessing the impact of changes to supplement timelines, given that biosimilar supplement review is a relatively new function and it is difficult to predict the volume and nature of topics that may need to be addressed in supplements,” and expressed concern that labeling reviews for biosimilars may be “complex.”
BsUFA Meeting Summaries


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Tags: BsUFA, FDA

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