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|
|Requiring Clinical data||$1,746,745||$1,746,745||0|
|Not requiring clinical data||$873,373||$873,373||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.