Pink Sheet
Scrip
Medtech Insight
HBW Insight
Generics Bulletin
In Vivo
Generics Bulletin
HBW Insight
In Vivo
Medtech Insight
Pink Sheet
Scrip
Industry Hails ‘Common Sense’ FDA Rethink On Non-US Comparators For Biosimilars
New Guidance Eliminates Need For Three-Way PK Study
Mar 11 2026
•
By
Dave Wallace
The guidance will make it easier for biosimilars developers to rely on non-US comparators
(Shutterstock)
More from Biosimilars
More from Products