FDA issues new guidance for biosimilar user fees

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The US Food and Drug Administration (FDA) has issued final guidance on the structure of the agency’s user fee programme under the Biosimilar User Fee Act of 2017 (BsUFA II).

User Fee V13H23

In the final guidance, which replaces the previous guidance of June 2018 [1], the FDA has outlined how certain fees will be eliminated and how the agency’s authority to collect fees has been extended from fiscal year (FY) 2018 through FY 2022.

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
Date: January 2020

The original BsUFA was passed into law in 2012, enabling FDA to collect user fees, which have played an important role in expediting the process for the review of biosimilars. The BsUFA must be reauthorized every five years, and in August 2017, the US President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the BsUFA through fiscal year 2022.

This guidance describes the types of user fees authorized by BsUFA II, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment.

The BsUFA II authorizes the collection of three types of fees:
1) Biosimilar biological product development program fees (BPD fees)
2) Biosimilar biological product application fees (application fees)
3) Biosimilar biological product program fees (program fees)

Product development fees include an initial fee (for new sponsors when they enter the BPD program), an annual fee and a reactivation fee (for sponsors that wish to resume a halted program).

Full product application fees are required for biosimilars that require clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness. For biosimilars that don’t require clinical data for safety and effectiveness one-half of a full application fee must be paid.

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

BsUFA II eliminates fees for supplements as well as for establishments. Applicants will be assessed annual biosimilar biological product program fees, rather than the biosimilar biological product fees assessed under BsUFA I.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on biosimilar user fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 28]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-biosimilar-user-fees

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Source: US FDA

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