FDA Announces Biosimilar User Fee Act Rates for FY2018

U.S. FDA News

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018.  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, the FDARA reauthorized BsUFA through 2022.

The new rates for FY2018, as compared to the rates for FY2017, are as follows:

Fee category Fee rate for FY2017 ($) Fee rate for FY2018 ($)
Initial biological product development (BPD) 203,810 227,213
Annual BPD 203,810 227,213
Reactivation 407,620 454,426
Applications:

Requiring clinical data

Not requiring clinical data

2,038,100

1,019,050

 

1,746,745

873,373

Program N/A* 304,162

 

*In FY2017, instead of a program fee, FDA charged a fee for establishment ($512,200) and for product approval ($97,750).

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