A paper from the brand-backed Alliance for Safe Biologic Medicines disputes the US Food and Drug Administration conclusion that biosimilar switching studies may not be necessary for interchangeability, calling the study supporting it “overreaching.”
Key Takeaways
-
The Alliance for Safe Biologic Medicines, which includes brand biologic companies Amgen, Abbvie and Genentech, said in a published paper that an FDA analysis suggesting switching between biosimilars and reference products does not increase safety risks was flawed.
-
The group said the analysis was highly selective and admittedly limited and the conclusions were overreaching
In
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?