Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products
This article was originally published in The Pink Sheet Daily
Executive Summary
Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.
You may also be interested in...
Biosimilars: FDA Closes Out 2016 With Clinical Pharmacology Guidance
While industry awaits US FDA guidance on interchangeability, agency finalizes document on clinical pharmacology data to support a demonstration of biosimilarity – years ahead of May 2019 target date in commitment letter for user fee program's renewal.
Biosimilars: FDA Closes Out 2016 With Clinical Pharmacology Guidance
While industry awaits US FDA guidance on interchangeability, agency finalizes document on clinical pharmacology data to support a demonstration of biosimilarity – years ahead of May 2019 target date in commitment letter for user fee program's renewal.
Biosimilars: FDA’s Four-Tiered Assessment Draws Industry Scrutiny
PhRMA asks FDA to remove the categorization of a product as not similar, similar, highly similar, or similar with fingerprint-like similarity.