FDA Releases BsUFA II Fees for FY 2020

The FDA has issued its biosimilar user fee rates for FY2020, showing a notable decrease in reactivation and product development fees.

While application fees have remained the same as last year, fees for initial biological product development (BPD) and reactivation have gone down. The fees are as follows:

• Initial BPD – $117,987
• Annual BPD – $117,987
• Reactivation – $235,975
• Applications requiring clinical data – $1,746,745
• Applications not requiring clinical data – $873,373
• Program fee – $304,162

The BsUFA II FY 2020 fees come into effect on October 1.