FDA Approves Sanofi's Merilog As First Rapid-Acting Insulin Biosimilar Product For Diabetes

On Friday, the FDA approved Sanofi SA’s SNY Merilog as a biosimilar to Novo Nordisk A/S‘ NVO Novolog (insulin aspart) for improving 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.

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As a rapid-acting insulin, Merilog helps lower mealtime blood sugar spikes and improve blood sugar control in people with diabetes. The approval is for a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial.

Merilog is the third insulin biosimilar product the FDA has approved, joining the two long-acting insulin biosimilar products the agency approved in 2021.

A biosimilar is a “biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product).” The FDA has approved 65 biosimilar products to date.

Like Novolog, Merilog should be administered within five to ten minutes before the start of a meal. Merilog is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs, or upper arms. Dosing of Merilog should be individualized and adjusted based on the patient’s needs.

Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain, and swelling of hands and feet.

In 2023, Sanofi jumped the bandwagon with the other two insulin U.S. giants to lower the price of its best-selling insulin product, Lantus (insulin glargine), by 78%.

Sanofi said it would cap a Lantus patient’s monthly out-of-pocket cost at $35 for all patients with commercial insurance.

Also, in 2023, Sanofi acquired Provention Bio for $25.00 per share in cash, representing an equity value of approximately $2.9 billion.

The transaction adds a type 1 diabetes therapy to Sanofi’s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile.

In November, Doctors Without Borders/Médecins Sans Frontières highlighted that Eli Lilly And Co LLY, Novo Nordisk, and Sanofi, which dominate the global insulin market, have the power to set high prices that restrict access.

According to MSF, data published in JAMA Network Open shows that insulin pens could be produced for as little as $0.94 per unit and remain profitable, yet current prices far exceed this figure.

Price Action: SNY stock is down 0.59% at $54.18 during the premarket session on last check Tuesday.

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