BsUFA talks continue on technology, regulatory science and reviews
The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March.During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. (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).
At the 6 April meeting, industry presented its proposal for best practices in application review, which would include opportunities for public engagement with FDA and updates to FDA documents. FDA inquired about potential topics for public engagement and the two sides discussed options to streamline the proposal.
Industry was keen on seeing FDA develop a data and technology modernization strategy and modernize its Electronic Submission Gateway (ESG) and presented proposals related to those topics. FDA in turn presented its proposal for moving some of its systems to cloud-based technology and the two parties discussed means of identifying and prioritizing technology demonstration projects related to biosimilars.
The two sides discussed financing, hiring and retention under BsUFA II and expectations for BsUFA III. FDA said it expects similar financial flexibilities from the previous program to be baked into the next iteration and gave proposals to advance its resource capacity planning capability and to improve hiring and retention of review staff. Industry offered its own proposals on the topic, which also extended to financial transparency and accountability, as well as management of the program’s carryover balance.
FDA also suggested some technical changes that would ease certain administrative aspects of the program and said it would provide industry with examples at a future meeting.
During the 13 April meeting, FDA and industry continued talks on regulatory science, human factors and use-related risk analysis (URRA) review timelines and supplements and labeling for product safety updates.
FDA gave a presentation on its objectives for the BsUFA III regulatory science program, which would focus on facilitating efficient biosimilar and interchangeable product development and enhancing regulatory decision-making. The two sides discussed the proposal and industry “agreed to discuss regulatory science internally and revisit in a future meeting.”
The agency went over its proposal for review timelines for human factors protocols and URRA and agreed to return to the table with language clarifications and details on the scope of URRA reviews. Resource levels required to meet the proposed timelines are still up for discussion.
FDA also responded to industry’s earlier proposal on labeling for product safety updates, and the two sides discussed its potential implications. The two sides also agreed to “revisit” FDA’s supplement proposals from the 30 March meeting at the next meeting on 20 April.