FDA

First rapid-acting insulin biosimilar approved

February 19, 2025

FDA approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, the first rapid-acting human insulin analog biosimilar product approved by the FDA, helps to lower mealtime blood sugar spikes to improve control of blood sugar. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.

Merilog is the third insulin biosimilar product approved by the FDA and joins the two long-acting insulin biosimilar products approved in 2021 by the FDA.

Similar to Novolog, Merilog should be administered SC within five to ten minutes prior to the start of a meal. Dosing should be individualized and adjusted based on the patient’s needs.

Merilog may cause serious side effects, including hypoglycemia, severe allergic reactions, and hypokalemia. Other common side effects may include injection site reactions, pruritus, rash, lipodystrophy, weight gain, and swelling of hands and feet.

Sources:

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

Merilog. Package insert. Food and Drug Administration. 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761325Orig1s000lbl.pdf