Follow-On Pathway Necessary For Industry To Be Invested, Woodcock Says
Executive Summary
"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.
You may also be interested in...
FDA Biologic Manufacturing Comparability Policy May Apply To Follow-Ons
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
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
FDA Clears Omnitrope; Product Is Not The Process, But Nor Is It A Pathway
Sandoz' approval for the first follow-on version of a human growth hormone product relies on data from a Phase III clinical program that studied 89 pediatric patients