FDA Approves Insulin Biosimilar for Glycemic Control in Patients With Diabetes

On February 14, the FDA approved insulin-aspart-szj, an insulin analog and a biosimilar to insulin aspart, to improve blood sugar control in patients with diabetes. The fast-acting insulin product is designed to be administered subcutaneously within 5 to 10 minutes prior to the start of a meal. The drug is approved for both pediatric and adult use in either 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,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release.

Insulin-aspart-szj is now the third insulin biosimilar to be approved by the FDA, expanding safe and effective treatment options available to the approximately 8.4 million Americans who currently rely on insulin therapy to manage their diabetes.

“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,” Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said. “Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA.”

Like its reference product, insulin aspart, insulin-aspart-szj’s side effects include hypoglycemia, severe allergic reactions, and hypokalemia. The most common side effects reported include injection site reactions, itching, rash, weight gain, and lipodystrophy.

Reference
FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes. February 14, 2025. Accessed February 21, 2025: https://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes