FDA Issues Final Guidance on BsUFA II Fees

The FDA released guidance on the agency’s BsUFA II fee structure finalizing the changes introduced since BsUFA I — including that biosimilars will no longer be assessed supplemental or establishment fees and the number of program fees per year will be limited to five per company.

The final guidance covers fiscal years 2018 to 2022 and largely reflects the November 2017 draft, spelling out the three types of fees: initial or annual biological product development program (BPD) fees, biosimilar biological product application fees and biosimilar program fees.

Sponsors are assessed BPD fees when they enter the initial product development program. They also must pay an annual BDP fee at the beginning of each fiscal year as long as the product remains in active development. Sponsors who wish to resume halted development of a biosimilar must pay a reactivation fee that is double the annual BPD fee.