FDA approves biosimilar insulin product

July 29, 2021

The U.S. Food and Drug Administration (FDA) has approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes and in adults with Type 2 diabetes.

Semglee is interchangeable with its reference product Lantus, a long-acting insulin analog. Semglee is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes, the FDA said.

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).

The FDA said that an interchangeable biosimilar product may be substituted for the reference product without the intervention of a 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.

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