FDA Approves Second Interchangeable Lantus Biosimilar


Lilly’s Rezvoglar is a long-acting human insulin analog. It follows Semglee as a biosimilar that can be substituted for Lantus for both adults and children with diabetes.

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.

Recent Videos
Video 5 - "Obstacles in Adapting Diabetes Technology to Individual Needs" - 1 KOL is featured
Video 4 - "The Impact of Continuous Glucose Monitors & Digital Solutions on Diabetes Care"
Video 3 - "The Pivotal Role of Patient Engagement and Education in Achieving Optimal Diabetes Outcomes"
Video 2 - "Addressing Coexisting Conditions: Keys to Comprehensive Diabetes Care"
Video 1 - "The Influence of Social Determinants of Health on Diabetes Care and Outcomes"
Video 6 - "Failing to Reach Ideal Diabetes Care: Equitable Doesn’t Mean Equal"
Video 5 - "Revising Diabetes Outcome Measures"
Video 10 - "Managing Self Care"
Video 3 - "Embracing and Improving Access to Technology Tools"
Video 8 - "Demographic Differences That Impact Care"
Related Content
© 2024 MJH Life Sciences

All rights reserved.