Blog Big Molecule Watch October 11, 2022

FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2023

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2023 fiscal year, which runs from October 1, 2022 through September 30, 2023.  The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), which was signed into law on August 18, 2017.

The new rates for FY2023, compared with the rates for FY2022, are as follows:

Fee Category Fee Rate for FY2023 (USD) Fee Rate for FY2022 (USD)
Initial biological product development (BPD) $47,325 $57,184
Annual BPD $47,325 $57,184
Reactivation $94,650 $114,368
Applications:

Requiring clinical data

Not requiring clinical data

 

$1,746,745

$873,373

 

$1,746,745

$873,373

Program $304,162 $304,162

The FDA provided following estimates for FY 2023: (i) the FDA will receive eight applications for biosimilar products requiring clinical data for approval and none that do not require clinical data; (ii) the FDA will invoice 72 biosimilar biological product program fees; and (iii) the FDA will collect fees for approximately 23.5 new BPD programs and approximately 97.75 annual BPD programs.

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