The FDA is considering changing its policy on biosimilars to make it easier for companies, clinicians, and patients. Currently, pharmacists can’t substitute a lower-cost biosimilar for a brand-name biologic without FDA approval. To become interchangeable, a biosimilar must undergo clinical trials, but the FDA is now considering removing this requirement. Lawmakers, like Senator Mike Lee, have criticized the cost and delay caused by these trials. The FDA is seeking feedback on this potential change, which would align the U.S. with Europe’s approach to biosimilars. Comments are open until Sept. 20.
Source link
FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars
