Tag: biosimilars
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.
Immunogenicity in Biosimilars: Why Immune Responses May Differ from Reference Biologics
Biosimilars aren't exact copies of biologics-tiny manufacturing differences can trigger immune responses. Learn why some patients develop anti-drug antibodies and how this affects treatment safety and effectiveness.
What Are Biosimilars? A Simple Guide for Patients
Biosimilars are highly similar versions of complex biologic drugs, approved by the FDA to be as safe and effective as the original. Unlike generics, they’re not exact copies but offer major cost savings without compromising care.