The Biosimilar User Fee Program has announced the new FY 2025 fee schedule in the pre-publication of the Federal Register Notice (here). The base fee amount for the BsUFA program for FY 2025 is $51,058,823, which is adjusted for inflation (this year is calculated at 4.1881%); along with factoring in other required estimated expenses, this results in a total estimated collection amount of $56,012,000. The BsUFA legislation provides for the collection of certain fees with the percentages of the total amount that should be collected for each fee type. The description of the individual fee calculations and the method for reaching the FY 2025 fees appears in the FR Notice. The FY 2025 fee structure for the biosimilar program is presented below.
BsUFA Fees for FY 2025
BPD = Biosimilar biological Product Development
While the BPD fees remained the same as the FY 2024 fees, the FY 2025 application fees rose substantially. The FY 2024 application fees requiring clinical data and those not requiring clinical data were set at $1,018,753 and $509,377, respectively. The program fee also rose from the FY 2024 fee of $177,397.
The biosimilar program in the U.S. has been very robust over the last few years. Will the rise in fees, the complexity associated with biosimilar reimbursement, and, in some instances, the weak biosimilar uptake have a negative impact on the growth of this segment of the industry in the future? Only time will tell.
