Pink Sheet 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 Fees: Industry, FDA Tussle On Ramp-Up Speed For Program

This article was originally published in The Pink Sheet Daily

Executive Summary

Industry says performance goals should not be phased-in, but FDA says it does not have enough money to be full-strength at launch.

You may also be interested in...



Biosimilar User Fee Program Stresses FDA/Sponsor Meetings Early And Often

BsUFA agreement negotiated between the agency and industry provides five different types of meetings during the pre-IND and product development stage. FDA will issue a draft guidance on the different types of biosimilar meeting opportunities by 2014.

Biosimilar User Fee Agreement Includes “Financial Hold” On Development Programs For Failure To Pay

Biosimilar INDs could be placed on “financial hold” if sponsors fail to timely pay product development fees under FDA’s inaugural biosimilar user fee deal with industry.

How Should FDA Collect The Biosimilar Product Development Fee?

FDA looking at different ways and development milestones to charge the pre-marketing application fee.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS072513

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