Towards the end of last year, the United States Food and Drug Administration (FDA) opened a public docket to solicit comments on the reauthorization of the Biosimilar User Fee Act for fiscal years 2023 through 2027 (BsUFA III). Currently, BsUFA authority expires in September 2022, and this reauthorization process is necessary for the FDA to continue collecting user fees in future fiscal years.
What is BsUFA?
BsUFA authorizes FDA to assess and collect fees from drug companies that submit marketing applications for biosimilar biological products and was originally enacted in 2012 as the Biosimilar User Fee Act under the Food and Drug Administration Safety and Innovation Act, to last for a period of 5 years. In 2017, BsUFA was renewed for five more years under the FDA Reauthorization Act of 2017. BsUFA’s intent is to provide additional revenues so that FDA can hire staff, improve systems, and continue a well-managed biosimilar biological product review process to make biosimilar biological product therapies available to patients sooner.
During prior BsUFA authorizations, the FDA agreed to certain performance and procedural goals with industry. For example, under BsUFA II, the FDA agreed to create an independent fee structure to ensure stable and predictable user fee funding, improve the predictability of FDA funding and sponsor invoices, improve efficiency by simplifying the administration of user fees, and enhance flexibility of financial mechanisms to improve management of BsUFA program funding. In addition, the FDA agreed to improve the hiring and retention of critical review staff through modernization of FDA’s hiring system, augmentation of hiring staff capacity and capabilities, creation of a dedicated function focused on staffing the program, reporting on hiring metrics, and a comprehensive and continuous assessment of hiring and retention.
BsUFA III
In the request for comments, the FDA requested information pertaining to three general questions:
(1) what is your assessment of the overall performance of the BsUFA program to date?
(2) what current elements should be retained, changed, or discontinued to further strengthen and improve the program?
(3) what new elements should the FDA consider adding to the program to enhance the efficiency and effectiveness of the biosimilar biologic review process?
In response to the request, the FDA received seven comments that sought more explicit guidance from the FDA on interchangeable biosimilar products.
In the comment submitted on behalf of the Biosimilars Forum, Andrea Maresca noted that while the “FDA has published several guidance documents related to biosimilars, industry continues to struggle with the lack of clarity regarding the Agency’s policy on certain aspects of interchangeability as well as regulatory expectations for certain post-approval changes for biosimilar or interchangeable products,” specifically noting that the FDA has excluded interchangeable biologics from its biosimilar guidance documents.
Arlene Wolny, PhD, MBA, with Sandoz, also called for more interchangeability information from FDA to reduce development risks for industry. In its submission, the company recommended that the agency develop interchangeable guidance focused on promotion and advertising, labeling, product presentation, and categories of post-approval process changes.
Anna Hyde, writing on behalf of the Arthritis Foundation, also called out interchangeability as an area where FDA could be doing more patient education, writing, “[c]learing up lingering points of confusion can help increase confidence in biosimilars, and in particular biosimilars that are not deemed interchangeable.”
“While we have not yet seen an interchangeable product licensed under BsUFA II, we will very likely see one during the five years encompassed by BsUFA III,” Cory Wohlbach of Teva Pharmaceuticals, wrote on behalf of the Association for Accessible Medicines (AAM) Biosimilars Council. “For companies seeking interchangeability approval for their biosimilars, clear guidance to industry on remaining issues will significantly facilitate development and regulatory review, leading to increased patient access to the valuable therapies.
What’s Next?
The comment period closed mid-December 2020, so at this point, the FDA will review the submitted comments and begin negotiations with industry on BsUFA III reauthorization.