FDA Biosimilar User Fee Rates: Fiscal Year 2019

On Tuesday, July 31st, FDA released a notice with updated biosimilar user fee rates for fiscal year 2019. The base revenue for FY 2019 is $40,214,000, not adjusted for inflation or operating reserves.

FDA has decided that the FY 2019 biosimilar application fee will be $1,746,745, which is the same as 2018.  Application fees are expected to account for 40% of the total target revenue for FY 2019.

The 2019 biosimilar program fee will also remain the same as the FY 2018 fee ($304,162), and will account for approximately 18% of the total target revenue.

Finally, the remainder 42% of revenue will come from BPD fees, which are set at $185,409, which is 18% less than last year.

Fee Category FY 2019 Fee Rates FY 2018 Fee Rates
Initial BPD $185,409 $227,213
Annual BPD $185,409 $227,213
Reactivation $370,818 $454,426
Applications Requiring Clinical Data $1,746,745 $1,746,745
Applications Not Requiring Clinical Data $873,373 $873,373
Program $304,162 $304,162


Are you in the process of developing a biosimilar product? We can help.  With fees as high as they are, we know how important it is to get things done right the first time around and are focused on working with you to achieve successful outcomes with the FDA.  Contact us today to learn more about our services and how we can help you with all things FDA related.