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 Fee Collections Drop Well Below Estimates, But US FDA Not Worried

Executive Summary

The agency hopes application volume increases, but warns the biosimilar user fee revenue will remain volatile.

You may also be interested in...



US FDA Making BsUFA III Regulatory Science Grants Available Early

Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.

US FDA Making BsUFA III Regulatory Science Grants Available Early

Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.

FY 2019 Drug Development Drives FY 2021 User Fees Lower

Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS125437

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