Regulatory science pilot floated in BsUFA III negotiations

Regulatory NewsRegulatory News | 15 June 2021 |  By 

In the latest rounds of negotiations for the reauthorization of the Biosimilar User Fee Act (BsUFA III), industry and the US Food and Drug Administration (FDA) fine-tuned labeling and supplements language, sought to find new ways for developers to receive targeted feedback, and set the scope for future guidance documents.
In a series of three May 2021 meetings, the BsUFA III negotiation steering committee convened to work on these topics, and to hammer out an agreement for best practices during the application review process. Representatives from FDA’s Center for Biologics Evaluation and Research (CBER) as well as staff from the Center for Drug Evaluation and Research (CDER) attended the meetings, as did industry representatives from the Association for Affordable Medicines, BIO, PhRMA and the Biosimilars Forum.
Regarding supplements and labeling for product safety updates, FDA committed to preparing draft commitment letter language and an estimate of resources required, while industry representatives set forth a proposed timeline for the updates, which FDA is considering.
During May, FDA and industry also considered the format and timing for meetings for targeted feedback; FDA also shared proposed fixes to the Type 4 meeting process, which industry is considering. By the end of the month’s meetings, FDA and industry also “discussed and identified meeting management metrics that would be useful to collect and report.”
Both industry and FDA agreed on the importance of prioritizing guidance topics surrounding the area of biosimilar interchangeability; industry asked for, and FDA provided, a detailed roadmap for supporting both guidance development and scientific research on the interchangeability topic. (RELATED: BsUFA III negotiations turn to supplements, technology proposals, Regulatory Focus 26 May 2021)
Branching off from this, FDA put forth a proposal for a pilot regulatory science program, which industry expressed support for, though they had queries for the agency regarding how the pilot would be evaluated, and what the scale of the program would look like. On 19 May, industry presented a counterproposal “with clear demonstration projects and deliverables.” FDA, according to the minutes, indicated general agreement with the "proposed structure and topic areas for demonstration projects.”
By the 19 May meeting, FDA was able to provide high-level estimates of resources required for previously negotiated BsUFA III agenda items. Industry queried the methodology used to arrive at the estimates, and FDA provided its estimation methodology. Further discussions touched on how to use the carryover balance from BsUFA II.
Minutes from a 25 May BsUFA III negotiation meeting are not available at press time, but guidance development, regulatory science advancement, and resource commitments were slated to be discussed.
Minutes are also available for late May and early June negotiation meetings for reauthorization of the Generic Drug User Fee Amendments of 2017 program (GDUFA III).
These minutes, as sparse as previous GDUFA III minutes have been, note that industry members “provided thoughts on the proposals for setting a sound foundation for continued programmatic success” on 3 June.  (RELATED: Capacity adjustments, DMFs under discussion for GDUFA III, Regulatory Focus 12 May 2021)
On the same date, FDA and representatives of the generics industry also talked about ways to enhance meeting options for complex generic development. FDA also presented “a few proposals” for how to handle abbreviated new drug applications that miss their goal date. Options reviewed included boosting transparency “around senior management awareness” and having an option for annual reporting, according to the minutes.
The single-sentence minutes for 20 May also note that the meetings are setting a foundation for continued programmatic success, but also provide the updates that attendees considered whether capacity planning adjustment plans would be appropriate, and that complex generics proposals were considered.
BsUFA III minutes
GDUFA III minutes


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