Sanofi Wins FDA Nod for Merilog, First Rapid-Acting Insulin Biosimilar

The FDA has approved Sanofi’s Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar product for the treatment of diabetes.

Merilog is a biosimilar to Novo Nordisk’s NovoLog, a widely used rapid-acting insulin aspart.

Merilog is approved for use in adults and pediatric patients six years of age and older. The approval includes both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial of the biosimilar.

Insulin aspart is a rapid-acting insulin analog used to manage blood sugar levels in individuals with type 1 and type 2 diabetes. It is typically administered via subcutaneous injection and begins to take effect approximately 15 minutes post-injection, with a duration of action lasting three to five hours.

Biosimilars are biological products highly similar to an already FDA-approved reference product, with no clinically meaningful differences in terms of safety, purity and potency.

More than 38 million people in the US have diabetes, a condition characterized by elevated blood glucose (sugar) levels. Approximately 8.4 million Americans depend on insulin therapy — either rapid-acting, long-acting or both — to regulate their blood sugar.

Insulin, a hormone produced by the pancreas, allows glucose to enter cells for energy. In individuals with diabetes, the pancreas either produces insufficient insulin or none at all, resulting in uncontrolled blood sugar levels that can lead to serious health complications.

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“The FDA has now approved three biosimilar insulin products to treat diabetes,” said Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER).

“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.”

In July 2021, the FDA approved Semglee (insulin glargine-yfgn) from Biocon and Viatris as the first biosimilar to Lantus. Just five months later, Eli Lilly received regulatory approval for its own version, Rezvoglar (insulin glargine-aglr).

Given the high cost of insulin, which has forced some patients to ration their supply, US lawmakers have been making calls for pharmaceutical companies to lower prices.

NovoLog and Novo Nordisk’s other rapid-acting insulin, Fiasp, is among some of the drugs up for price negotiations under the Inflation Reduction Act, with new pricing set to take effect at the beginning of next year.

In response to mounting pressure over high insulin prices, Eli Lilly announced a 70% price cut for most of its insulins in 2023, followed by Novo Nordisk’s 75% reduction for NovoLog less than two weeks later. Shortly after, Sanofi joined in, slashing the price of Lantus by 78% and implementing a $35 monthly out-of-pocket cap for commercially insured patients.

Merilog’s approval is supported by a Phase III trial, which included 597 patients with type 1 and type 2 diabetes who received several shots of the insulin aspart biosimilar every day. At Week 26, those who received the biosimilar and those on the reference product had similar blood sugar levels, demonstrating Merilog’s non-inferiority.

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