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
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.