Zdrowie i gospodarka · 04/08/2020

FDA Announces Biosimilar User Fee Rates for Fiscal Year 2021

The Food and Drug Administration (FDA) has announced the biosimilar user fee rates for fiscal year 2021, which will be in effect from October 1, 2020, to September 30, 2021. The rates are set by the Biosimilar User Fee Amendments of 2017 (BsUFA II), which authorizes the FDA to collect fees for biosimilar biological product development and review.