The U.S. Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj), a Novolog (insulin aspart) biosimilar, for the control of glycemia in adults and pediatric patients with diabetes mellitus. Merilog is the first FDA-approved rapid-acting insulin biosimilar and is available as a 3 mL prefilled pen and a 10 mL multiple-dose vial. Merilog reduces mealtime blood sugar surges, allowing for improved control of diabetes.
Merilog is the third FDA-approved insulin biosimilar, following the two long-acting insulin biosimilars approved in 2021. Availability of biosimilars increases treatment options and expands patient access to safe and effective therapies at potentially lower prices.
Peter Stein, M.D., director of the FDA‘s Office of New Drugs, highlighted the FDA‘s commitment to maximizing biosimilar approval efficiency to foster competition and affordability. Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars, added that biosimilar insulins could make life-saving treatments accessible to millions who depend on daily insulin therapy.
Biosimilars are biologic medications that are very similar to an approved reference product, with no clinically meaningful differences in safety or efficacy. The FDA has approved 65 biosimilars for many medical conditions.
Diabetes affects more than 38 million people in the U.S., and 8.4 million Americans depend on rapid-acting and/or long-acting insulin. Insulin is vital for glucose regulation, and its absence can cause severe health consequences.
Similar to Novolog, Merilog should be administered by injection 5-10 minutes before meals to the stomach, buttocks, thighs, or upper arms. Dosage is tailored to individual patient needs.
Potential severe side effects can include hypoglycemia (low blood sugar), anaphylactic reactions, and hypokalemia (low potassium). Side effects can include reactions at the injection site, itching, rash, weight gain, and swelling.
The approval of Merilog represents a significant advance in diabetes treatment, offering a more convenient and less expensive treatment for patients.
