Last week, the U.S. Food and Drug Administration published the Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022. Commonly referred to as the “goals letter” or “commitment letter,” the publication represents discussions among FDA, the regulated industry, and public stakeholders regarding reauthorization of the Biosimilar User Fee Act (“BsUFA”).
Written by Scot B. Pittman
BsUFA authorizes FDA to collect user fees for the review of biosimilar biological product applications. The current legislative authority for biosimilar user fees expires in September 2017, and FDA cannot continue to collect user fees without reauthorization. Relatedly, on Monday, FDA announced that it will hold an upcoming public meeting to discuss proposals for reauthorization. The proposals include enhancements to the existing biosimilars user fee program in four key areas: (i) review performance; (ii) meeting management; (iii) guidance development, and (iv) fee/program administration.