The advancement in diabetes management has progressed with the FDA’s approval of Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin-aspart). This is the first rapid-acting insulin biosimilar available on the market, providing adults and children who need to manage their glucose levels with an alternative option. Its rapid-acting human insulin analog helps control blood sugar levels that rise during meals. It provides variable treatment choices and is available in a 10-mL multiple-dose vial and a 3-mL single-patient-use prefilled pen.
Following the approval of two long-acting insulin biosimilars by the FDA in 2021, Merilog has become the third insulin biosimilar medication to be approved by the FDA. Individuals living with diabetes now have better access to cost-effective alternatives to treatment owing to the advent of biosimilars, which has increased market competition.
The FDA is now accepting three biosimilar insulin products for the management of diabetes, this is a significant move, according to Dr. Peter Stein, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. The grant of clearance, therefore, demonstrates our continuing attempts to enhance the biosimilar approval procedures’ efficiency in order to promote market competition and offer access to costly therapies like insulin.
Merilog’s approval advances wider healthcare endeavors to enhance accessibility and reduce the cost of insulin. The cost of insulin continues to be an issue, but biosimilars bring hope for more affordable alternatives.
Biosimilars are remarkably comparable to an original medicine that has received prior FDA approval; there have been no clinically significant modifications in terms of quality, safety, or efficacy. Patients currently have additional treatment alternatives owing to the FDA’s acceptance of 65 biosimilar drugs in a variety of therapeutic areas.
In the US, roughly 38 million individuals struggle with diabetes, but 8.4 million of them are dependent on insulin therapy. Insulin is required in managing blood sugar levels along with minimizing complications like cardiovascular disease, renal disease, and nerve damage. A larger number of people will be given access to the insulin they need, owing to the availability of biosimilars.
Merilog is administered five to ten minutes before meals, which is identical to Novolog. It is injected subcutaneously into the thighs, upper arms, or stomach. For optimal blood sugar control, dosages need to be adjusted.
Hypokalemia, injection site responses, hypoglycemia, and lipodystrophy are possible adverse effects. To choose the appropriate course of therapy, patients need to discuss it with the appropriate medical expert.
Through Merilog’s FDA approval, the availability of rapid-acting insulin solutions has expanded, reflecting a significant turning point in the treatment of diabetes. Millions of people could be able to cope with diabetes more successfully when biosimilar medications become more readily available due to their promise to reduce costs and enhance patient outcomes.
References: U.S. Food and Drug Administration. FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes. Published February 14, 2025. Accessed February 12, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetesÂ
