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