FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2019

Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2019 fiscal year, which runs from October 1, 2018 through September 30, 2019.  The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017.  Among other things, FDARA reauthorized BsUFA through 2022.

The new rates for FY2019, compared with the rates for FY2018, are as follows:

Fee Category Fee Rate for FY2019 (USD) Fee Rate for FY2018 (USD)
Initial biological product development (BPD) $185,409 $227,213
Annual BPD $185,409 $227,213
Reactivation $370,818 $454,426
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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