FDA finalizes guidance for efficient biosimilars meetings, per BsUFA III

The US Food and Drug Administration (FDA) published on 18 July a final, 23-page guidance document clarifying how sponsors may formally meet with the agency regarding the development and review of their biosimilars, including interchangeable products.

The latest reauthorization of the Biosimilar User Fee Act (BsUFA III) included performance goals for efficiently and predictably managing formal meetings between FDA and sponsors.

“The good meeting management practices in this guidance are intended to provide consistent procedures that will promote well-managed meetings and to ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately,” FDA officials wrote in the guidance document.

The guidance applies to products regulated by the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Formal meetings include in-person, phone, and video appointments as well as written responses, FDA explained. The final guidance outlines six types of formal meetings between requesters and FDA staff to discuss the development and review of biosimilar products: Biosimilar Initial Advisory (BIA), Biological Product Development (BPD) Type 2a, BPD Type 2b, BPD Type 3, and BPD Type 4.

“Changes from the draft to the final guidance include clarification that requesting a Biosimilar Initial Advisory meeting is not a requirement prior to joining the Biosimilar Biological Product Development program, additional description of in-person meetings and core attendees, and a description regarding the maximum number of questions that should be submitted within a single meeting request,” FDA noted in a Federal Register announcement.

During the BIA, FDA and the sponsor have a general discussion about the proposed product, as opposed to a substantive review of summary data and study reports, and the agency makes a preliminary decision about prospects for licensing.

“If the requester is seeking targeted advice on the adequacy of any comparative data or extensive advice for any aspect of a planned or ongoing biosimilar, including interchangeable biosimilar, product development program, a different meeting type should be requested,” FDA wrote.

“Requesting a BIA meeting is not a requirement prior to joining the BPD program,” the agency added.

According to the guidance, in-person meetings have a virtual component to allow participation of non-core participants.

“Because the intent is that the primary discussion occurs face-to-face in person, all sponsors and FDA individuals who are key to such discussions (i.e., “core” attendees) should participate, if feasible, in person,” FDA explained. “Individuals expected to have a more peripheral role (e.g., may be called on to comment on a single question) may participate virtually.”

FDA outlines best practices for requesting meetings. For example, it asks sponsors to be specific about areas on which they need input, the stage of product development, and to provide lists of planned sponsor attendees and requested FDA attendees. The number of questions per meeting, including sub-questions, should be capped at 10.

“The objectives and agenda provide overall context for the meeting topics, but it is the list of questions that is most critical to understanding the kind of information or input needed by the requester and to focus the discussion should the meeting be granted,” FDA guided. “Each question should be precise and include a brief explanation of the context and purpose of the question.”

The final guidance follows an August 2023 draft of the same name, which itself represented an update on guidance on the topic from 2018 (RELATED Biosimilar meetings: FDA updates draft guidance for BsUFA III, Regulatory Focus, 11 August 2023).

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FDA finalizes guidance for efficient biosimilars meetings, per BsUFA III

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