FDA Approves First Interchangeable Biosimilar Insulin

Miriam E. Tucker

July 28, 2021

The US Food and Drug Administration (FDA) has approved the first interchangeable insulin, Semglee (Mylan Pharmaceuticals), which can be substituted for glargine (Lantus, Sanofi) at the pharmacy without the need for a separate prescription.

The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.

It is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.

Originally approved in June 2020 as a biosimilar to glargine, Semglee is now an "interchangeable biosimilar," meaning that it has no clinically meaningful difference from the reference product and also may be substituted for that product — in this case, glargine (Lantus) — without prescriber intervention, just as generic drugs typically are, subject to state pharmacy laws.

For approval as an interchangeable biosimilar, manufacturers are required to provide additional data reflecting how the interchangeable biosimilar may be used in the marketplace with patients.

"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," said Peter Stein, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, in an FDA statement. "The FDA's high standards for approval mean healthcare professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product."

"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 US typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products," the FDA notes in their statement.

Semglee comes in 10-mL vials and 3-mL prefilled pens, and is administered subcutaneously once daily, with individualized doses. The most common side effects are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions.

The FDA released new materials for health care providers regarding biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.

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