The FDA has approved a rapid-acting human insulin biosimilar to Novolog (Novo Nordisk), insulin-aspart-szjj (Merilog; Sanofi-Aventis), for glycemic control in adults and pediatric patients with diabetes mellitus.1
This approval makes insulin-aspart-szjj the first rapid-acting insulin biosimilar approved and the third insulin biosimilar approved by the FDA, after insulin glargine-aglr (Rezvoglar; Eli Lilly) and insulin glargine-yfgn (Semglee; Mylan).
“The FDA has now approved 3 biosimilar insulin products to treat diabetes,” Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement about the approval. “This 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.”
More than 38 million people in the United States have been diagnosed with diabetes, and approximately 8.4 million Americans rely on insulin therapy 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.
Like Novolog, Merilog should be administered within 5 to 20 minutes before the start of a meal.
Adverse events noted for insulin-aspart-szjj included hypoglycemia, severe allergic reactions, and hypokalemia. Other common side effects may include injection-site reactions, itching, rash, lipodystrophy, weight gain, and swelling of hands and feet.
The FDA granted approval of Merilog to Sanofi-Aventis U.S. LLC.
References
FDA. FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes [press release]. February 14, 2025. Accessed February 19, 2025. www.prnewswire.com/news-releases/fda-approves-first-rapid-acting-insulin-biosimilar-product-for-treatment-of-diabetes-302377321.html</li>