The FDA announced the FY 2021 biosimilar user fees this morning on its Federal Register pre-publication page (here).  The new fees can be found in the table below.

BSUFA FY 2021 User fees

Fee Category Rates for FY 2021 Rates for FY 2020 Percent Change
Initial BPD $102,494 $117,987 -13.2%
Annual BPD $102,494 $117,987 -13.2%
Reactivation $204,988 $235,975 -13.2%
Requiring Clinical data $1,746,745 $1,746,745 0
Not requiring clinical data $873,373 $873,373 0
Program $304,162 $304,162 0


All of the BSUFA pre-application fees decreased this year, which indicates that the number of biosimilar biological product development (BPD) engagements shows a growing program.  Fees for applications and the program fee remained unchanged.  The new fees will be applicable for all biosimilar applications submitted on or after October 1, 2020.