BsUFA III negotiations turn to supplements, technology proposals

The US Food and Drug Administration (FDA) issued a proposal for reviewing new supplements and establishing new supplement categories while both industry and the agency discussed plans to upgrade FDA’s information technology (IT) infrastructure, according to minutes from recent Biosimilar User Fee Act (BsUFA) Reauthorization steering committee meetings.
 
BsUFA, originally enacted in 2012, authorizes FDA to collect fees from biosimilar developers to help fund the agency’s review program. FDA and industry negotiate terms for the agreement and establish a set of performance goals and commitments for the five-year program; the third BsUFA iteration is now under consideration. User fee revenue expedites the process for reviewing biosimilar product submissions, including applications, supplements, notifications, responses and meeting management.
 
The meetings were held 27 April and 20 April; the minutes were released on 21 May. In addition to supplement review and IT, the steering committee discussed labeling for product safety updates, meeting management, finance and staffing enhancements, guidance development and best practices for application review.
 
Industry was represented in these meetings by the Biotechnology Innovation Organization (BIO), the Association for Accessible Medicines (AAM), the Biosimilars Forum and the Pharmaceutical Research and Manufacturers of America (PhRMA).
 
Supplements
 
The topic of supplements was on the agenda for both meetings. At the 20 April meeting, FDA and industry “shared updated thinking on supplement proposals. Industry highlighted the importance of clear and predictable timelines for supplement review.”
 
FDA in turn “described the complexity of supplement categories and emphasized the need for careful consideration of categories and review timelines” and agreed to provide additional clarity on its proposed supplement categories and review timelines.
 
FDA subsequently presented an updated proposal on supplement categories and review timelines at the 27 April meeting. The agency further noted that its supplement proposals are contingent on resources while industry agreed to consider FDA’s proposed supplement categories and timelines.
 
Information technology
 
Information technology infrastructure was another major topic area discussed, and at the 27 April meeting, FDA commented on industry’s proposals for a data and technology modernization strategy for its Electronic Submissions Gateway system, and FDA reviewed these proposals to leverage cloud technology to “progress regulatory digital transformation.” Both FDA and industry “discussed resources associated with these proposals.”
 
FDA discussed its proposal for a demonstration project to support cloud innovation specific to biosimilar applications. Industry agreed to consider the demonstration project and the resource estimates for the proposal.
 
Items on the 4 May meeting agenda are to “revisit” discussions on supplements, labeling for product safety updates, meeting management, guidance development and best practices during application review.
 
A spokesperson for PhRMA declined to comment on the negotiations to Focus, but said that in public comments last year, the group outlined its BsUFA funding priorities: to optimize FDA staffing and resources, improve the IT infrastructure, and supports biosimilar and interchangeable product development and prompt updates to safety information. The spokesperson said the group will be providing comments upon the release of the goal letter later this year.
 
27 April meeting minutes
 
20 April meeting minutes