Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul

Executive Summary

BsUFA revenue amounts and fees will be separated from PDUFA and relative contribution of each fee type to the overall pot will change; user fee revenue target for program's first year is $45m.

You may also be interested in...



User Fees For FY 2017 Make Sponsors Happy, Manufacturers Sad

Several facility fees will increase next year as application fees drop.

Amgen's Humira Biosimilar Gains Nod From Panel Perplexed By Regulatory Pathway

Time and again, FDA officials had to explain the importance of the analytical characterization data in the biosimilar development paradigm.

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

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

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB002438

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel