The guidance was released in June 2018 and 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.

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
Date: June 2018
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf

Draft guidance on this subject was released by FDA for public comment in November 2017. The comment period closed on 16 January 2018. The final guidance covers fiscal years 2018 to 2022 and largely reflects the November 2017 draft. BsUFA II authorizes the collection of three types of fees:

1) biosimilar biological product development programme fees (BPD fees)
2) biosimilar biological product application fees (application fees)
3) biosimilar biological product programme fees (programme fees).

New sponsors must pay an initial BPD fee when they enter the BPD programme. They must then 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 twice the annual BPD fee.

It eliminates fees for biosimilar supplements and establishments. It also limits the number of programme fees per year to five per company. The guidance also outlines the sanctions the agency will take for unpaid fees.

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