FDA Details New User Fee Structure for Biosimilars

In a final guidance, the FDA outlined the new structure of the user fee program under the Biosimilar User Fee Act of 2017 (BSUFA II) which eliminated certain fees and extended the agency’s authority to collect fees through fiscal 2022.

BSUFA II authorized the collection of three types of fees — product development program fees, application fees and program fees — and eliminated fees for supplements and for establishments.

Product development fees include an initial fee, an annual fee and a reactivation fee. The initial fee is due within five days after the agency grants the first product development meeting for the product or upon submission of an IND application to support a biosimilar application.

Annual fees are collected in the next fiscal year after the initial product development fee has been paid. Reactivation fees for sponsors who want to re-join the biological product development (BPD) program will be twice the amount of the annual BPD fee established for that fiscal year.

Program fees are assessed annually for each named applicant for each product identified in an application approved as of October 1 of that fiscal year that is not discontinued.