On February 14, 2025, the U.S. Food and Drug Administration (“FDA”) approved Sanofi-Aventis U.S. LLC’s (“Sanofi”) MERILOG™ (insulin-aspart-szjj), a biosimilar to Novo Nordisk A/S’s (“Novo Nordisk”) NOVOLOG® (insulin aspart), for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. MERILOG™ helps to lower mealtime spikes in blood sugar concentrations and to improve control of blood glucose levels. The FDA approved both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 mL multiple-dose vial.
Sanofi’s MERILOG™ is now the first insulin aspart biosimilar, and the third insulin biosimilar product to be approved by the FDA, behind Biocon’s SEMGLEE® (insulin glargine-yfgn) and Eli Lilly’s REZVOGLAR™ (insulin glargine-aglr), both approved in 2021. The insulin glargine products are long-acting human insulin analogs, which generally take around 1-2 hours to start lowering blood sugar and then maintain a steady insulin level, whereas insulin aspart is a rapid-acting human insulin analog that takes around 15 minutes to start working but lasts for a shorter duration.
According to the FDA, more than 38 million people in the United States have been diagnosed with diabetes, and approximately 8.4 million Americans rely on insulin therapy, either rapid-acting or long-acting, to manage the condition. As we have previously reported, multiple companies occupying the insulin market have announced price reductions for various products in recent years, with some reductions taking effect starting January 1, 2026.
Stay tuned to Big Molecule Watch for further developments in the biosimilars market.