Insulin Management

FDA Approves First Interchangeable Biosimilar Insulin Product

The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar insulin product for the treatment of type 1 and type 2 diabetes in adults and children.

In addition to being biosimilar, this new insulin product, Semglee (insulin glargine-yfgn), is also interchangeable with its reference product, a long-acting insulin analog, Lantus (insulin glargine). This insulin is to be offered in 10 mL and 3 mL prefilled pens and administered subcutaneously once per day.

Semglee should not be given during hypoglycemic episodes, or in those with hypersensitivity to insulin glargine products. It is not recommended for treating diabetic ketoacidosis. Potential side effects include hypoglycemia, severe allergic reactions, hypokalemia, and heart failure. Edema, lipodystrophy, weight gain, and allergic reactions are among the most common side effects.

“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,” FDA officials concluded. “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.”


—Leigh Precopio



FDA approves first interchangeable biosimilar insulin product for the treatment of diabetes. News release. US Food and Drug Administration; July 28, 2021.