FDA Schedules Public Meeting and Request for Comments on Biosimilar User Fee Act

Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027.  We have previously reported on BsUFA rates for the 2022 fiscal year.  The BsUFA authorizes FDA to collect user fees to support the review of biosimilar biological product applications.  According to FDA, “the BsUFA is intended to provide additional revenues so that FDA can hire staff, improve systems, and continue a well-managed biosimilar biological product review process.”  The current legislative authority for BsUFA expires in September 2022, and without new legislation, FDA would no longer be able to collect user fees.

The proposed changes to the reauthorization of the BsUFA relate to “[s]upplemental applications, meeting management, best practices in communication between FDA and sponsors, inspections and alternative tools, interchangeable biosimilar biological product development, regulatory science, finance, hiring and retention, and information technology.”  FDA also issued a commitment letter concerning the performance and goals for the reauthorization of the BsUFA, including FDA’s goal to “[r]eview and act on 90 percent of original biosimilar biological product application submissions within 10 months of the 60 day filing date.”

The public meeting will be held on November 2, 2021, from 9 a.m. to 12 p.m. EST via webcast.  Stay tuned for further updates.