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FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
The U.S. Food and Drug Administration 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, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (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. Approval of biosimilar products can increase patient access to safe and effective treatment options.
Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. 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 (also called the reference product). Patients can expect the same safety and effectiveness from the biosimilar as from the reference product. To date, the FDA has approved 65 biosimilar products for a variety of health conditions.
More than 38 million people in the U.S. have been diagnosed with diabetes, a disease that occurs when blood glucose (sugar) is too high. Approximately 8.4 million Americans rely on insulin therapy, either rapid-acting and/or long-acting, to manage diabetes. Insulin, a hormone made by the pancreas, helps glucose get into a person’s cells to be used for energy. With diabetes, the pancreas doesn’t make enough insulin to keep blood sugar levels in the normal range, which can lead to serious health problems for patients.
Like Novolog, Merilog should 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. Dosing of Merilog should be individualized and adjusted based on the patient’s needs.
Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet.
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