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

FDA Biologic Manufacturing Comparability Policy May Apply To Follow-Ons

Executive Summary

FDA's comparability guidance for biologics undergoing manufacturing process changes could be used to establish standards for the approval of generic biologics, according to former agency reviewers

You may also be interested in...



Follow-On Pathway Necessary For Industry To Be Invested, Woodcock Says

"The Pink Sheet" sat down with FDA Chief Medical Officer Janet Woodcock to discuss the agency's forthcoming guidances related to follow-on proteins. Woodcock testified that the agency is in the process of developing guidance for approval of follow-on biologics under the 505(b)(2) pathway at the House Oversight and Government Reform Committee hearing on generic biologics March 26 (1"The Pink Sheet" April 2, 2007, p. 13). Woodcock has been a long-time champion of the scientific issues that underscore the follow-on debate, including the need for the terminology of "follow-on proteins" to be clear that the products are biotech proteins.

Follow-On Pathway Necessary For Industry To Be Invested, Woodcock Says

"The Pink Sheet" sat down with FDA Chief Medical Officer Janet Woodcock to discuss the agency's forthcoming guidances related to follow-on proteins. Woodcock testified that the agency is in the process of developing guidance for approval of follow-on biologics under the 505(b)(2) pathway at the House Oversight and Government Reform Committee hearing on generic biologics March 26 (1"The Pink Sheet" April 2, 2007, p. 13). Woodcock has been a long-time champion of the scientific issues that underscore the follow-on debate, including the need for the terminology of "follow-on proteins" to be clear that the products are biotech proteins.

505(b)(2) Resurrection, FDA Guidance To Bless Follow-On Biologics Pathway

FDA's decision to develop guidance for development of follow-on versions of biologics approved under the Food, Drug & Cosmetic Act indicates the agency has accepted section 505(b)(2) of the FD&C Act as a viable pathway for approval of such products

UsernamePublicRestriction

Register

LL035386

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