FDA Approves Merilog as Biosimilar to Insulin Aspart for Diabetes

The FDA approved insulin-aspart-szjj (Merilog) as a biosimilar to insulin aspart (Novolog) for the improvement of glycemic control in adults and pediatric patients with diabetes. The drug is the first rapid-acting insulin biosimilar product approved for use by the FDA, marking a significant milestone in diabetes treatment. This is the third insulin biosimilar product approved by the FDA.¹

This is the third insulin biosimilar product approved by the FDA. | Image Credit: Araki Illustrations | stock.adobe.com

“The FDA has now approved 3 biosimilar insulin products to treat diabetes,” Peter Stein, MD, director of the office of new drugs in the Center for Drug Evaluation and Research in the FDA, said in a news release. “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.”¹

While other insulin biosimilars have been approved, they have been primarily for long-acting insulins. Rapid-acting insulin, like insulin aspart, is crucial for managing post-meal blood sugar spikes, making this approval particularly impactful for mealtime glycemic control. Insulin aspart is a rapid-acting, human insulin analog to improve glycemic control for type 1 and type 2 diabetes in adults and children and inhibits the breakdown of glucose, fat, and amino acids. Insulin-aspart-szjj, the biosimilar, helps to lower mealtime blood sugar spikes, controlling blood sugar.^1,2

The new biosimilar should be administered within 5 to 10 minutes prior to the start of a meal and is subcutaneously injected. While insulin-aspart-szjj offers a promising new option for diabetes management, it is essential to be aware of potential adverse effects (AEs). These can include injection site reactions, itching, rash, lipodystrophy, weight gain, and swelling of the hands and feet. Patients should discuss these potential AEs and any concerns with their health care providers. The approval is a 3 mL single-patient-use refilled pen and a 10 mL multiple-dose vial.¹

“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,” Sarah Yim, MD, director of the office of therapeutic biologics and biosimilars in the Center for Drug Evaluation and Research in the FDA, said in the release.¹

This approval offers a cost-saving opportunity for patients and also fosters a more competitive market for insulin products. As the FDA continues to streamline the biosimilar approval pathway, patients can look forward to increased access to safe and effective alternatives to costly biologic medications. This will ultimately improve their quality of life and health outcomes. This approval marks a positive step towards ensuring that essential medications like insulin are accessible and affordable for all who need them.¹

REFERENCES

1. FDA approves first rapid–acting insulin biosimilar product for treatment of diabetes. News release. FDA. February 14, 2025. Accessed February 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes?utm_medium=email&utm_source=govdelivery

2. Rubin R, Khanna NR, McIver LA. Aspart Insulin. [Updated 2024 Jun 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK500030/