PARIS (dpa-AFX) - The U.S. Food and Drug Administration announced that Sanofi-Aventis U.S. LLC's Merilog (insulin-aspart-szjj) becomes the first rapid-acting insulin biosimilar product to get its approval for the treatment of diabetes in adults and pediatric patients.
Merilog has been approved as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval is for both a 3 milliliter or mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.
As a rapid-acting human insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes.
Like Novolog, Merilog is required to be administered within five to ten minutes prior to the start of a meal. Merilog is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs or upper arms. Merilog's dosing needs to be individualized and adjusted based on the patient's needs.
Meanwhile, Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). It may also cause other common side effects such as injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet.
Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, said, '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.'
The FDA noted that Merilog is the third insulin biosimilar product to get its approval. In 2021, the agency had approved two long-acting insulin biosimilar products.
A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA. It gives the same safety and effectiveness from the biosimilar as from the reference product.
According to the FDA, approval of biosimilar products can increase patient access to safe and effective treatment options. So far, the FDA has approved 65 biosimilar products for a variety of health conditions.
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