WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently approved Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar to Novolog (insulin aspart). This new treatment option, aimed at enhancing glycemic control for individuals with diabetes mellitus, offers a critical milestone in the pursuit of increased access to effective and affordable healthcare.
Merilog, classified as a rapid-acting human insulin analog, is designed to reduce mealtime blood sugar spikes, improving blood sugar management for adults and pediatric diabetes patients. This newly approved biosimilar will be available in two forms—a 3-milliliter prefilled pen for single-patient use and a 10-milliliter multiple-dose vial—providing versatile options for those requiring insulin.
“The FDA has now approved three biosimilar insulin products to treat diabetes,” noted Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s 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.”
This approval further strengthens the significance of biosimilar products, which are biological medications highly similar to existing FDA-approved products. Just like their reference counterparts, biosimilars provide the same safety and efficacy, while encouraging a competitive marketplace that may result in cost savings for patients. Merilog marks the third insulin biosimilar to receive FDA approval, following the greenlight of two long-acting biosimilar insulin products in 2021.
Diabetes, a chronic disease impacting more than 38 million Americans, requires rigorous daily management to prevent severe complications. Approximately 8.4 million people in the U.S. depend on rapid-acting or long-acting insulin therapies to help regulate their blood glucose levels. By producing a hormone naturally made by the pancreas, insulin ensures that glucose from food is absorbed into cells for energy. For individuals with diabetes who do not produce enough of this hormone, insulin remains a life-saving intervention.
“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,” 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 is administered subcutaneously (under the skin) before meals, typically within five to ten minutes of starting a meal. Injection sites may include the stomach, thighs, buttocks, and upper arms. Like similar rapid-acting insulins, Merilog must be dosed according to individual patient needs. However, it also carries potential risks, including hypoglycemia (low blood sugar), severe allergic reactions, and hypokalemia (low potassium levels). Common side effects include itching at the injection site, swelling, rash, and mild weight gain.
The FDA approved Merilog to Sanofi-Aventis U.S. LLC, further emphasizing its ongoing commitment to increasing the availability of high-quality and affordable medication options. The approval fills a critical gap in the insulin market, where rapid-acting options have been historically limited in terms of cost-effective alternatives.
Looking ahead, biosimilar products are expected to play an essential role in reshaping diabetes care by expanding treatment options, lowering costs, and improving healthcare equity. For millions of Americans relying on insulin therapy, advancements like Merilog offer renewed hope for managing one of the nation’s most prevalent chronic conditions while lightening the economic burden tied to essential diabetes treatments.
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