The Federal Register announced the BsUFA fees for FY 2022 today (here) and, for the second year in a row, the fees have decreased or, in the case of applications, stayed the same.
| Fee Category | Rates for FY 2021 | Rates for FY 2022 | Percent Change |
| Initial BPD | $102,494 | $57,184 | -44.3 |
| Annual BPD | $102,494 | $57,184 | -44.3 |
| Reactivation | $204,988 | $114,368 | -44.3 |
| 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 |
Well, business looks good in the biosimilars arena. After last year’s drop of 13.1% in BPD and reactivation fees, the projected numbers of submissions must be skyrocketing as this year those fees dropped another 44.3%. This is also impacted by higher fees producing an overestimation of costs and excess of revenue as the program was stood up.
