Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Biosimilar User Fee Reboot: Resource Challenges Make FDA Eye New Structure

This article was originally published in The Pink Sheet Daily

Executive Summary

Fee rates for biosimilars could be decoupled from new drug user fees in order to provide more predictable revenue stream.


Related Content

Celltrion's Biosimilar Strategy Includes Simultaneous EMA/FDA Reviews
Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul
PDUFA Fees Forced Down For FY 2017 Due To Refund Provision
PDUFA VI: Innovative Trial Design Talks Can’t Have Formal Meeting Goals, FDA Says


Related Companies