Biosimilars Forum Releases Position on Non-Medical Switching
WASHINGTON, D.C., June 27, 2018 – The Biosimilars Forum opposes any legislative efforts that limit biosimilar utilization via a prohibition on non-medical switching from one medicine to another that the Food and Drug Administration (FDA) has approved as a biosimilar to the original medicine.Explanatory Paragraph
“Non-medical switching” or “non-medical substitution” are terms that refer to formulary-driven changes between drug options that are thought to be therapeutically equivalent, but that are very different in structure. In contrast, biosimilars and interchangeable biologics are proven to be highly similar in both structure and function to their reference products. Because a transition from a reference product to a biosimilar is between two highly similar products that the FDA has explicitly found to have no clinically meaningful differences, the Forum believes that the concept and terms of “non-medical switching” and “non-medical substitution” do not apply to biosimilar or interchangeable biologic products.
About the Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.
Anthony Hogrebe, Marathon Strategies