Naming Biological Medicines
May 9, 2019
Patients with chronic and complex conditions like rheumatoid arthritis, high cholesterol and Crohn’s disease are among the many people who benefit from innovative biological medicines.
Unlike traditional drugs, biological medicines derive from cells or living systems. They are typically infused or injected, either by a health care provider or through a self-injectable device patients use at home. Biosimilars – follow-on biological medicines – are highly similar to their biologic reference product and offer equally powerful results.
While biologics and biosimilars provide unprecedented treatment options, they also present unexplored policy issues. One important question for regulators has been: How will these medicines be named? The answer has implications for both access and patient safety.Biologics