Tag: FDA
The Purple Book: Biosimilars and Interchangeability Explained
The FDA's Purple Book is the official guide to biosimilars and interchangeable biological products in the U.S. It helps pharmacists, doctors, and patients understand which drugs can be swapped, why interchangeability matters, and how state laws affect substitution.
International Perspectives on NTI Generics: Regulatory Approaches Compared
NTI generics require stricter regulation than regular generics due to their narrow safety margin. This article compares how the FDA, EMA, Canada, and Japan handle bioequivalence, pricing, and substitution rules - and why global alignment is still a work in progress.