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% |
| Applications | |||
| 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.
