FDA approves Merilog (insulin-aspart-szjj) the first rapid-acting insulin biosimilar product for treatment of diabetes – Sanofi

The FDA has approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) from Sanofi 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. Like Novolog, Merilog should be administered within five to ten minutes prior to the start of a meal. Merilog is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs or upper arms.

The approval is backed by a phase III trial of 597 patients with type 1 and type 2 diabetes who received multiple shots daily. At week 26, blood sugar levels were similar for those who received the biosimilar and those on the reference product, confirming Merilog’s non-inferiority.

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.

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.”