FDA Lowers Some BsUFA II Fees for Fiscal 2019

The FDA released its BsUFA II fees for FY 2019, lowering biological product development fees from the fiscal 2018 rates while leaving application and program fees unchanged.

The new fees, which take effect Oct. 1, reduce the initial, annual and reactivation biological product development fees for sponsors.

The agency is cutting the initial BPD fee — due either when a sponsor submits an investigational new drug application intended to support a biosimilar biological product application or within five calendar days after the agency grants the product’s first BPD meeting — from $227,213 to $185,409.