FDA Approves Second Biosimilar Insulin Product for Diabetes - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Approves Second Biosimilar Insulin Product, Rezvoglar (insulin glargine-aglr)  

The Food and Drug Administration approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). Rezvoglar (insulin glargine-aglr) is biosimilar to Lantus (insulin glargine).

Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference product.

As a biosimilar product, Rezvoglar can be used in place of Lantus; however, the patient would need a prescription from a health care prescriber written specifically for Rezvoglar.

Rezvoglar is the second biosimilar insulin product and the 32nd biosimilar product approved in the U.S.

Rezvoglar, offered in 3 mL prefilled pens, is administered subcutaneously once daily. Dosing of Rezvoglar, like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin glargine products. Also, like Lantus, Rezvoglar is not recommended for treating diabetic ketoacidosis. Rezvoglar may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium in your blood) and heart failure. The most common side effects associated with insulin glargine products other than hypoglycemia include edema (fluid retention), lipodystrophy (pitting at the injection site), weight gain and allergic reactions, such as injection site reactions, rash, redness, pain and severe itching.

This approval furthers FDA’s longstanding commitment to support a competitive marketplace for insulin products. The availability of biosimilar and interchangeable insulin products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients.

For more information about biosimilar products, visit www.fda.gov/biosimilars.