The U.S. Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar to NovoLog (insulin aspart). This approval marks a significant step in expanding treatment options for individuals with diabetes, potentially improving accessibility and affordability of insulin therapy.

Merilog is indicated for glycemic control in adults and pediatric patients with diabetes and will be available in 3 mL prefilled pens and 10 mL multiple-dose vials. It is administered subcutaneously within 5 to 10 minutes before meals to manage mealtime blood sugar spikes.

While biosimilar insulin products have been approved previously, they have primarily been long-acting formulations. The approval of Merilog introduces a biosimilar alternative for rapid-acting insulin, which is essential for post-meal glucose management.

Clinical studies demonstrated that Merilog is highly similar to NovoLog, with no clinically meaningful differences in safety, purity, and potency. As with all insulins, potential side effects include hypoglycemia, allergic reactions, injection site issues, and weight gain.

The approval also aligns with the FDA’s ongoing efforts to streamline the biosimilar approval process to foster a more competitive insulin market. With 8.4 million Americans relying on insulin therapy, the introduction of Merilog could provide a lower-cost alternative for patients managing diabetes.

Sanofi, the manufacturer of Merilog, joins Eli Lilly and Novo Nordisk in efforts to reduce insulin prices, following significant price cuts for major insulin brands over the past year.

For more information, please visit Fierce Pharma.