FDA Approves First Rapid-Acting Insulin Biosimilar for Diabetes: Daily Dose

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On February 14, 2025, we reported on the US FDA approval of Merilog (insulin aspart-szjj), for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.

The approval

Merilog is the first rapid-acting insulin biosimilar and will be available in a 3-mL prefilled pen and a 10-mL multiple-dose vial. It 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.

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.

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