The U.S. Food and Drug Administration (FDA) has officially approved Merilog as a biosimilar to Novolog (insulin aspart). This is an exciting advancement for improving blood sugar control in adults and children with diabetes mellitus.
Merilog is a rapid-acting human insulin analog and is the first rapid-acting insulin biosimilar to receive FDA approval. It is specifically designed to help manage blood sugar spikes around mealtime, making it a reliable option for those looking to maintain their blood sugar levels.
Greater flexibility and convenience in diabetes management
Additionally, Merilog is available in two convenient formats: a 3 milliliter (mL) single-patient-use prefilled pen for easy dosing on the go and a 10 milliliter (mL) multiple-dose vial for those who prefer a different option. This approval provides greater flexibility and convenience in diabetes management, allowing individuals to feel more in control of their health.
Merilog is the third insulin biosimilar product approved by the FDA, joining the two long-acting insulin biosimilar products approved in 2021. Approval of biosimilar products can increase patient access to safe and effective treatment options.
“The FDA has now approved three biosimilar insulin products to treat diabetes,” said Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“The 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.”
Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes.
A biosimilar is a biological product 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 the reference product. The FDA has approved 65 biosimilar products for various health conditions.
38 million people in the U.S. have been diagnosed with diabetes
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.
“For the millions of people who rely on daily injections of insulin for the 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,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.
Merilog may cause serious side effects
Like Novolog, Merilog should be administered five to ten minutes before the start of a meal. It 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 the 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.