FDA gives Sanofi-Aventis green light for Novolog biosimilar

Sanofi Aventis has obtained the Food and Drug Administration's approval for Merilog (insulin-aspart-szjj), which is a biosimilar to Novo Nordisk's NovoLog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. 

Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (ml) single-patient-use prefilled pen and a 10 milliliter (ml) multiple-dose vial.

Merilog is the third insulin biosimilar product approved by the FDA and joins the two long-acting insulin biosimilar products approved in 2021 by the FDA. 

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"The FDA has now approved three biosimilar insulin products to treat diabetes," said Peter Stein, 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." 

More than 38 million people in the U.S. have been diagnosed with diabetes, a disease that occurs when blood glucose (sugar) is too high. Approximately 8.4 million Americans rely on insulin therapy, either rapid-acting and/or long-acting, 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, the FDA noted.

"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, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research.

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