FDA approves first insulin interchangeable biosimilar

The Food and Drug Administration (FDA) has approved the first interchangeable biosimilar insulin product meant to treat diabetes.

According to a news release, the product, Semglee (insulin glargine-yfgn), is indicated to improve glycemic control in adults and children with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. It is both biosimilar to and can be substituted for its reference product, long-acting insulin analog Lantus (insulin glargine). This is the first insulin biosimilar approved by the FDA and these products can give patients more safe, high-quality, and possibly cost-effective options to treat diabetes.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” Acting FDA Commissioner Janet Woodcock, MD, says in the release “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Biosimilars are biological products with no clinically meaningful difference from a product already approved by the FDA. Interchangeable biosimilars can be substituted for their reference product without direct action by the prescriber. When marketed in the U.S., biosimilars usually launch with initial list prices 15 percent to 35 percent lower than the list prices of the reference product, the release says.

This approval could be financial boon for the 34 million Americans who have been diagnosed with diabetes.

“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, says in the release. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”