Biosimilar meetings: FDA updates draft guidance for BsUFA III

The US Food and Drug Administration (FDA) published a revised draft guidance this week meant to help drugmakers developing biosimilars navigate when and how to convene meetings with the agency.

The 20-page draft guidance, titled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products, replaces a previous draft document of the same name released in June 2018, which in turn superseded a November 2015 final guidance that was withdrawn.

Among changes in the new draft are modifications to the data expectations in Biosimilar Initial Advisory (BIA) meeting requests, the addition of Biological Product Development (BPD) Type 2a meetings, alterations to when the background package is submitted for a BPD Type 4 meeting, updates to the description of available meetings formats and the addition of an option for a request for clarification.

FDA noted that the guidance provides recommendations to sponsors on formal meetings between the agency and applications regarding the development and review of either biosimilar or interchangeable biosimilar products, regulated by FDA’s Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

“For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester(s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., in-person, virtual (videoconference), teleconference or written response only (WRO)),” FDA explained.

The guidance also highlights the principles of good meeting management practices (GMMPs) and describes standardized procedures for “requesting, preparing, scheduling, conducting and documenting such formal meetings,” the agency continued.

Because biosimilar products meetings with industry “often represent critical points in the regulatory and development process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings,” asserted FDA, saying that the GMMPs discussed are meant “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 also pointed out that, under the latest reauthorization of the Biosimilar User Fee Act (BsUFA) III, the agency has pledged to uphold key performance goals that include meeting management goals for formal meetings that occur between FDA and requesters.

Importantly, the agency described “five types of formal meetings that occur between requesters and FDA staff to discuss development and review” of a biosimilar or interchangeable product: BIA, BPD Type 1, BPD Type 2, BPD Type 3 and BPD Type 4.

However, sponsors do not need to request the meetings in sequential order and FDA said that while it would generally grant “one BIA meeting and one BPD Type 4 meeting for a particular biosimilar or interchangeable product, requesters can request, as appropriate, as many BPD Type 2 and Type 3 meetings as needed to support the development and review of a biosimilar or interchangeable product.”

Meeting types explained

“A BIA meeting is an initial assessment limited to a general discussion” regarding whether licensure for a product is feasible, FDA explained, saying this is where the agency gives general advice on “the expected content” of a sponsor’s development program. But the draft guidance clarified that this type of meeting does not include a substantive review of summary data or full study reports.

Next, a BPD Type 1 meeting is “a meeting that is necessary for an otherwise stalled development program to proceed or a meeting to address an important safety issue,” continued FDA, noting that examples of this type of meeting include addressing a clinical hold, safety issue or assessment of special protocols.

Whereas, says FDA, a BPD Type 2 meeting is used to discuss a specific issue “(e.g., ranking of quality attributes; chemistry, manufacturing, and controls such as control strategy; study design or endpoints; post-approval changes) or questions for which the FDA will provide targeted advice regarding an ongoing development program.” This type of meeting may include substantive review of summary data but not full study reports.

By contrast, a BPD Type 3 meeting is “an in-depth data review and advice meeting regarding an ongoing development program,” explained FDA, which includes “substantive review of full study reports or an extensive data package (e.g., detailed and robust analytical similarity data).” It also includes FDA advice “regarding the similarity between the proposed biosimilar or interchangeable product and the reference product based on a comprehensive data package,” and agency advice “regarding the need for additional studies, including design and analysis, based on a comprehensive data package,” according to the draft guidance.

Lastly, said the document, a BPD Type 4 meeting is a presubmission meeting used “to discuss the format and content of a complete application for an original biosimilar or interchangeable product application or supplement … The purpose of this meeting is to discuss the format and content of the planned submission and other items.”

FDA said this meeting may include identification of studies that the sponsor is relying on to support a demonstration of biosimilarity or interchangeability, as well as a discussion of any potential review issues identified based on the information provided, among other topics.

Draft guidance

Biosimilar meetings: FDA updates draft guidance for BsUFA III

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