FDA Approves Second Interchangeable Lantus Biosimilar

The FDA has approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine). Eli Lilly’s Rezvoglar (insulin glargine-aglr) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes. FDA previously approved Rezvoglar as a biosimilar to Lantus on Dec. 17, 2021. An interchangeable status now allows Rezvoglar to be substituted for Lantus at the pharmacy level.

Related: FDA Approves First Interchangeable Biosimilar Insulin

Rezvoglar is the second approved interchangeable biosimilar insulin in the United States. Rezvoglar joins Viatris’ Semglee (insulin glargine-yfgn), the first approved interchangeable biosimilar to Lantus, that FDA approved on July 28, 2021. Payer acceptance of Semglee has been uneven. Prime Therapeutics and Express Scripts have added Semglee to their preferred formularies, but OptumRx has excluded Semglee.

Rezvoglar is available in 3 mL prefilled pens and is administered subcutaneously once daily. Rezvoglar may cause serious side effects, including hypoglycemia, severe allergic reactions, hypokalemia 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.