FDA Approves Merilog, First Rapid-Acting Insulin Biosimilar for Diabetes

The US Food and Drug Administration (FDA) has approved the first rapid-acting insulin biosimilar, Merilog (insulin aspart-szjj), for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus, according to an FDA news release.¹

Merilog is a biosimilar to Novolog (insulin aspart) and will be available in a 3-mL prefilled pen and a 10-mL multiple-dose vial. Merilog joins two long-acting insulin biosimilar products approved in 2021, bringing the total to three insulin biosimilars available in the United States.¹

“The FDA has now approved three biosimilar insulin products to treat diabetes,” said Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in the news release. “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. Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA.”¹

More than 38 million people in the United States have been diagnosed with diabetes. Among them, approximately 8.4 million depend on insulin therapy. Merilog is administered by subcutaneous injection into the abdomen, thighs, buttocks, or upper arms and should be given 5 to 10 minutes before a meal. Dosage should be individualized and regularly adjusted based on patient needs.

“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,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, in the news release.

Adverse events associated with Merilog may include hypoglycemia, severe allergic reactions, and hypokalemia. Common adverse events include injection site reactions, itching, rash, lipodystrophy, weight gain, and edema.

Reference

1. U.S. Food and Drug Administration. FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes. Published February 14, 2025. Accessed February 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes