FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes

The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday.

Like its reference counterpart, insulin aspart (Novolog), the biosimilar helps lower mealtime blood sugar spikes to improve glycemic control. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.

“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 of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement.

Like reference insulin aspart, the biosimilar should be administered subcutaneously by injection into the stomach, buttocks, thighs, or upper arms within 5 to 10 minutes before the start of a meal. Dosing is individualized and adjusted based on the patient’s needs.

The drug’s serious side effects include hypoglycemia, severe allergic reactions, and hypokalemia. Other side effects include injection site reactions, itching, rash, lipodystrophy, weight gain, and swollen hands and feet.

The rapid-acting insulin aspart biosimilar joins two prior long-acting insulin biosimilar products approved in 2021. Biosimilars are highly similar to already approved products and have no clinically meaningful differences in safety and efficacy, the FDA stated. Patients can expect the same safety and effectiveness from a biosimilar as from the reference product.

“The FDA has now approved three biosimilar insulin products to treat diabetes,” said Peter Stein, MD, director of the Office of New Drugs at 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.”

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