The U.S. Food and Drug Administration (FDA) has reached a significant milestone in diabetes care by approving insulin-aspart-szjj (Merilog), the first rapid-acting insulin biosimilar in the United States. Developed by Sanofi-Aventis, this new biosimilar references Novo Nordisk's insulin aspart (Novolog) and is approved for improving glycemic control in both adult and pediatric patients with diabetes mellitus.
Clinical Application and Administration
The newly approved biosimilar is designed to address mealtime blood sugar spikes, a crucial aspect of diabetes management. Available in two formulations - a 3 mL single-patient-use pre-filled pen and a 10 mL multiple-dose vial - Merilog should be administered subcutaneously 5 to 10 minutes before meals. Injection sites include the stomach, buttocks, thighs, or upper arms, with dosing individualized based on patient requirements.
Market Impact and Access
This approval marks a significant advancement in expanding treatment options for the estimated 38 million Americans living with diabetes, of whom approximately 8.4 million depend on insulin therapy. Dr. Peter Stein, director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research, emphasized the importance of this approval: "Today's approval highlights our continued efforts to improve the efficiency of the biosimilar approval process to help support a competitive marketplace and increase options for costly treatments, like insulin."
Safety Profile and Considerations
Healthcare providers should be aware of potential serious adverse effects, including:
- Hypoglycemia
- Severe allergic reactions
- Hypokalemia
Common side effects may include:
- Injection site reactions
- Itching and rash
- Lipodystrophy at the injection site
- Weight gain
- Swelling of hands and feet
Expert Perspective
Dr. Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at FDA's Center for Drug Evaluation and Research, highlighted the significance of this approval: "For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications."
This approval represents the third insulin biosimilar to receive FDA approval, following two long-acting insulin biosimilars approved in 2021, demonstrating the agency's commitment to expanding access to affordable diabetes treatment options.
