Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Biosimilars: Eight Is More Than Enough For FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Eight pre-IND and IND applications for biosimilar products have been submitted to the Division of Therapeutic Proteins in CDER's Office of Biotechnology Products, according to division Director Amy Rosenberg.

You may also be interested in...



FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings

Several sponsors appear to be taking advantage of the FDA’s biosimilar pathway, even though the agency has yet to clarify how it will handle the applications.

Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee

FDA seems content to negotiate a user fee for biosimilars in a manner that typifies the composition of the products: similar, but not the same, as the other user fee programs.

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Topics

UsernamePublicRestriction

Register

LL1126093

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