FDA Approves Merilog, Biosimilar Product of Insulin Aspart (Novolog) for Diabetes

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) approved insulin-aspart-szjj (Merilog) as a biosimilar product of insulin aspart (Novolog) for the treatment indication of glycemic control in adults and pediatric patients with diabetes mellitus.¹

FDA announced the approval of insulin-aspart-szjj, the first rapid-acting insulin biosimilar product, on February 14, 2025. This rapid-acting insulin offers patients a cheaper, thus more assessable, treatment option to lower mealtime blood sugar strikes to improve blood sugar control in individuals with diabetes. The FDA approved this treatment as both a 3 mL single-use prefilled pen and a 10 mL multiple dose vial.

This approval comes nearly 4 years after the FDA approved the first interchangeable biosimilar insulin product, insulin glargine-yfgn (Semglee), in July 2021.² The FDA also had approved another long-acting insulin biosimilar in 2021 called insulin glargine-aglr (Rezvoglar). Until now, no approved insulin biosimilar had been rapid-acting.³

“For the millions of people who rely on daily injections of insulin for the 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.¹

More than 38 million people in the US have been diagnosed with diabetes, and about 8.4 million Americans rely on insulin therapy—either rapid-acting or long-acting.

FDA directed that insulin-aspart-szjj should be administered subcutaneously—either into the stomach, buttocks, thighs, or upper arms—within 5 to 10 minutes before starting a meal. A patient should have an individualized and adjusted dose based on their needs.

Insulin-aspart-szjj can lead to serious adverse events, such as hypoglycemia, severe allergic reactions, and hypokalemia. The biosimilar product can also result in injection site reactions, itching, rash, skin thickening, weight gain, or swelling of the hands or feet.

“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. “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.”

References

1. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes. US Food and Drug Administration. February 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes. Accessed February 14, 2025.

2. FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes. US Food and Drug Administration. July 28, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes. Accessed February 14, 2024.

3. FDA Approves Insulin Biosimilar Rezvoglar. December 9, 2022. Cardiometabolic Health Congress. https://www.cardiometabolichealth.org/article/rezvoglar-insulin-biosimilar-approved-by-fda/#:~:text=Rezvoglar%20has%20now%20received%20the,level%20without%20requiring%20physician%20permission.&text=The%20FDA%20had%20previously%20approved,Lantus%20on%20December%2017%2C%202021. Accessed February 14, 2025.