Biosimilars: Rise In US FDA Approvals Means Lower Or Flat User Fees In FY 2020
Executive Summary
Fees for applications and approved products will stay the same, while product development levies will fall 36%, the FDA announces. The agency’s biosimilar activities are becoming more reliant on funding from the growing number of products approved and less on those still in development.
You may also be interested in...
US Biosimilar Fee Collections Fall Short
A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.
After Biosimilar Fee Collections Fall Short, US FDA Modifies Carryover Spend-Down Plan
A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.
Pfizer Is King Of The US Biosimilar Hill
Four biosimilar candidates are under US FDA review, including what could be Pfizer’s eighth biologic approved under FDA’s 351(k) biologics license application pathway.