FDA Approves First Rapid-Acting Insulin Biosimilar for Patients With Diabetes

WEDNESDAY, Feb. 19, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.

Merilog is a rapid-acting human insulin analog and the first rapid-acting insulin biosimilar product approved by the FDA. Administering Merilog subcutaneously five to 10 minutes before mealtime helps improve glycemic control in patients with diabetes. Both a 3-mL single-patient-use prefilled pen and a 10-mL multiple-dose vial are included in this approval.

Serious side effects reported with Merilog include hypoglycemia, severe allergic reactions, and low potassium levels in the blood. Common side effects include injection site reactions, itching, rash, skin thickening or pitting at the injection site, weight gain, and swelling of hands and feet.

“The FDA has now approved three biosimilar insulin products to treat diabetes,” Peter Stein, M.D., director of the Office of New Drugs in the FDA Center for Drug Evaluation and Research, said in an agency press release. “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.”

Approval of Merilog was granted to Sanofi-Aventis.

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