FDA approves insulin-aspart-szjj as biosimilar for diabetes treatment

FDA approves insulin-aspart-szjj as biosimilar for diabetes treatment | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved the first rapid-acting insulin biosimilar product for the treatment of diabetes, according to a press release from the federal agency. With the decision, insulin-aspart-szjj (Merilog; Sanofi-Aventis) is now approved as a biosimilar to insulin aspart (Novolog; Novo Nordisk) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.

Being a rapid-acting insulin, insulin-aspart-szjj helps to lower mealtime blood sugar spikes to improve control of blood sugar in diabetes patients. The approved indication for the biosimilar is for both a 3 mL single-patient-use pre-filled pen and a 10 mL multiple-dose vial.

With the approval, insulin-aspart-szjj is the third biosimilar product approved by the FDA, joining 2 long-acting insulin biosimilar products approved in 2021.

"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," said Peter Stein, MD, director, Office of New Drugs, Center for Drug Evaluation and Research, FDA.

"Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA," added Stein in a statement.

The FDA states that more than 38 million people in the United States has been diagnosed with diabetes, with approximately 8.4 million people in the US relying on insulin therapy as a rapid-acting or long-acting therapy to manage the disease.

“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, Office of Therapeutic Biologics and Biosimilars, Center for Drug Evaluation and Research, FDA.

The biosimilar, like Novolog, should be administered within 5 to 10 minutes prior to the start of a meal. Dosing for insulin-aspart-szjj—administered subcutaneously via injection into the stomach, buttocks, thighs, or upper arms—should be individualized and adjusted based on patient need.

Serious side effects, including hypoglycemia, severe allergic reactions and hypokalemia can be the result of using the newly-approved biologic, according to the FDA.

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, the federal agency stated.

Reference:

FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes. FDA. Press release. February 14, 2025. Accessed February 14, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes