Pfizer Petitions FDA To Deny Sandoz Omnitrope NDA; Test Case For Follow-On Biologics
This article was originally published in The Pink Sheet Daily
Executive Summary
Petition indicates that FDA may be close to a decision on Sandoz' 505(b)(2) submission for a follow-on version of human growth hormone. FDA decision will be landmark in development of regulatory pathway for follow-on biologics.
You may also be interested in...
Sandoz Omnitrope Gains First “Similar Biological” Positive Opinion In the EU
Recombinant-DNA growth hormone would be approved through new pathway by demonstrating comparable safety and efficacy to Genotropin.
Sandoz Omnitrope Gains First “Similar Biological” Positive Opinion In the EU
Recombinant-DNA growth hormone would be approved through new pathway by demonstrating comparable safety and efficacy to Genotropin.
Sandoz Sues FDA For Inaction On Omnitrope NDA
Lawsuit seeks a court declaration that the 505(b)(2) pathway “can be used for protein-based biologic drugs regulated under Section 505 of the FD&C Act.”