FDA Approves First Biosimilar of Novolog

The FDA has approved Sanofi’s Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) to improve glycemic control in adults and pediatric patients with diabetes.

Merilog is a rapid-acting human insulin analog and is the first rapid-acting insulin biosimilar product approved by the FDA. It 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 single-patient-use prefilled pen and a 10 milliliter multiple-dose vial.

Like Novolog, Merilog should be administered within five to 10 minutes before eating. Merilog is administered subcutaneously (under the skin).

Merilog is expected to be available on the U.S. market in July 2025, but a Sanofi spokesperson said they expect a transition period during which payers will assess whether to include Merilog on their formularies. “Merilog will be priced to optimize access and affordability with careful consideration of Sanofi’s industry-leading pricing principles,” the spokesperson said.

Sanofi will provide Merilog to patients for $35 or less for a 30-day supply, regardless of income or insurance status.

“Sanofi believes that no one should struggle to pay for their insulin, regardless of their income level or insurance status,” the spokesperson said. “This is why Sanofi has a suite of innovative and patient-centric savings programs to help most people reduce the cost of their diabetes medicine. We also provide free medications to qualified low- and middle-income patients as part of a number of patient assistance Programs across our therapeutic areas.

Novo Nordisk’s NovoLog has a list prices of $139.71 for FlexPen, $72.34 for 10 mL vial, and $134.37 for a PenFill Cartridge. Patients with commercial insurance whose coverage includes NovoLog may pay as little $35 for a 30 day supply, and Novo Nordisk in its terms says all savings from this offer accrue to the patient.

Merilog is the third biosimilar insulin product approved by the FDA. In 2021, the FDA approved two biosimilars of Lantus, an insulin glargine: Rezvoglar (insulin glargine-aglr) in December 2021 and Semglee (insulin glargine-yfgn) in July 2021.

More than 38 million people in the United States have been diagnosed with diabetes. 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.

“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, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a news release.

The International Diabetes Federation predicts that by 2045, 1 in 8 adults, approximately 783 million, will be living with diabetes, an increase of 46%. More than 90% have type 2 diabetes.