The U.S. Food and Drug Administration (FDA) approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.
Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.
Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.
An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.
More than 34 million people in the U.S. today have been diagnosed with diabetes, which is a chronic (long-lasting) health condition that affects how the body stores and uses sugars and other nutrients for energy. Most food is broken down into sugar (also called glucose) and released into the bloodstream. When blood sugar levels increase, it signals the pancreas to release insulin, which acts like a key to allow blood sugar to enter the body’s cells for use as energy. With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range.
The FDA granted approval of Semglee (insulin glargine-yfgn) to Mylan Pharmaceuticals Inc.