FDA Approves Sanofi’s Rapid Acting Insulin Biosimilar Merilog for Diabetes

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The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control in adults and pediatric patients with diabetes mellitus. The regulatory action makes Merilog the first rapid-acting insulin biosimilar to gain FDA approval.

According to the federal agency, the approval includes both a prefilled pen and a multi-dose vial, expanding treatment options for patients who require mealtime insulin management. Merilog also marks the third insulin biosimilar approved in the United States, following two long-acting biosimilars approved in 2021.¹

"The FDA has now approved three biosimilar insulin products to treat diabetes," said Peter Stein, MD, director, office of new drugs, FDA's Center for Drug Evaluation and Research, in a press 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."

The FDA recommends that Merilog be administered between five and 10 minutes prior to the start of a meal. Additionally, the agency stated that it should be administered subcutaneously by injection into the stomach, buttocks, thighs, or upper arms, and that dosing should be adjusted based on the patient's needs.

Common severe adverse events (AEs) of Merilog include hypoglycemia, severe allergic reactions, and hypokalemia, while more common AEs include injection site reactions, itching, rash, lipodystrophy, weight gain, and swelling of the hands and feet.

FDA statistics indicate that over 38 million people in the United States have been diagnosed with diabetes. Additionally, 8.4 million depend on either rapid-acting or long-acting insulin therapy to treat diabetes.¹

According to the World Health Organization, the number of people living with diabetes globally rose from 200 million in 1990 to 830 million in 2022. Additionally, the number of cases has been rising at a much faster rate in low- and middle-income countries compared to high-income countries. In 2022, an estimated 14% of adults were living with diabetes, while around 59% of all individuals living with diabetes were not on medication to treat the disease. In 2021, around 1.6 million people died from complications of diabetes, with 47% of all deaths occurring in people under 70 years of age.²

According to the International Diabetes Foundation (IDF), it is estimated that 783 million adults will be living with diabetes by 2045, a 46% increase from 2021. The IDF suggests that this is a result of urbanization, an increased aging population, decreasing levels of physical activities, and an increased prevalence of obesity and overweight. In Africa, cases of diabetes are expected to grow 134%, significantly greater than in any other region.³

Type 2 diabetes accounts for 90% of all cases. While it was previously more common in older people, changes in diet and rising levels of obesity have resulted in increasing levels in children, adolescents, and younger adults.⁴ In 2022, approximately 8.75 million people were living with Type 1 diabetes.⁵

"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, MD, director, office of therapeutic biologics and biosimilars, FDA's Center for Drug Evaluation and Research, in the press release.

References

1. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes. PR Newswire. February 14, 2025. Accessed February 17, 2025. https://www.prnewswire.com/news-releases/fda-approves-first-rapid-acting-insulin-biosimilar-product-for-treatment-of-diabetes-302377321.html

2. Diabetes. WHO. November 14, 2024. Accessed February 17, 2025. https://www.who.int/news-room/fact-sheets/detail/diabetes

3. Facts & figures. IDF. Accessed February 17, 2025. https://idf.org/about-diabetes/diabetes-facts-figures/

4. Type 2 diabetes. IDF. Accessed February 17, 2025. https://idf.org/about-diabetes/types-of-diabetes/type-2/

5. Type 1 diabetes. IDF. Accessed February 17, 2025. https://idf.org/about-diabetes/types-of-diabetes/type-1-diabetes/