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|
|Applications Requiring Clinical Data||$1,746,745||$1,746,745|
|Applications Not Requiring Clinical Data||$873,373||$873,373|