Blog Big Molecule Watch August 17, 2021

FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2022

Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2022 fiscal year, which runs from October 1, 2021 through September 30, 2022.  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 FY2022, compared with the rates for FY2021, are as follows:

Fee Category Fee Rate for FY2022 (USD) Fee Rate for FY2021 (USD)
Initial biological product development (BPD) $57,184 $102,494
Annual BPD $57,184 $102,494
Reactivation $114,368 $204,988
Applications:

Requiring clinical data

Not requiring clinical data

 

$1,746,745

$873,373

 

$1,746,745

$873,373

Program $304,162 $304,162

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