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 |
August 8, 2018
According to a recently released notice from the FDA, “the FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for...
August 8, 2018
The Biosimilar User Fee Act of 2012 (BsUFA) authorizes the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD). These user...
August 8, 2018
In order to expedite the review process of biosimilar biological products, FDA is authorized to assess and collect fees from sponsors. The fees are collected for various activities related to...