Rapid-Acting Insulin Biosimilar Receives FDA Approval for Diabetes

The FDA has approved insulin-aspart-szjj (Merilog) as a biosimilar to insulin aspart (Novolog; Novo Nordisk) for the improvement of glycemic control among adults and pediatric patients with diabetes mellitus. The approval for a 3 mL single-patient use prefilled pen and a 10 mL multiple-dose vial.¹

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“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,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a news release.¹

Diabetes signifies a group of diseases that impact how the body uses glucose. Although the main cause of diabetes differs by type, all lead to excess sugar in the blood, causing severe health issues.²

Among the more than 38 million individuals diagnosed with diabetes in the US, approximately 8.4 million rely on insulin therapy to manage diabetes. This includes either rapid acting and/or long acting.¹

Insulin-aspart-szjj is the first rapid-acting insulin biosimilar approved by the FDA, indicated to lower mealtime blood sugar spikes to improve control of blood sugar among individuals with diabetes. Insulin-aspart-szji joins 2 long-acting insulin biosimilars that were FDA-approved in 2021.¹

The FDA provided that insulin-aspart-szjj should be administered within 5 to 10 minutes prior to the start of a meal, subcutaneously by injection into the stomach, buttocks, thighs, or upper arms. A patient should have an individualized dose based on their needs.¹

Insulin-aspart-szjj could cause serious adverse effects, including hypoglycemia, severe allergic reactions, and hypokalemia. Other common adverse effects include injection site reactions, itching, rash, lipodystrophy, weight gain, and swelling of hands and feet, according to the FDA.¹

“The FDA has now approved three biosimilar insulin products to treat diabetes,” Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in a 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

REFERENCES

1. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes. FDA. News release. 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?utm_medium=email&utm_source=govdelivery

2. Diabetes. Mayo Clinic. News release. March 27, 2024. Accessed February 14, 2025. https://www.mayoclinic.org/diseases-conditions/diabetes/symptoms-causes/syc-20371444