Biosimilars: FDA, EMA Developing Common Data Package Guidance
This article was originally published in The Pink Sheet Daily
Executive Summary
Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.
You may also be interested in...
Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products
Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.
Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products
Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.
FDA Oversight By House To Focus On User Fees, Compounding Law
Among the Energy and Commerce Committee’s priorities are ensuring correct implementation of the generic drug and biosimilar user fee programs, whose launches have experienced some hiccups.