FDA Approval of First Rapid-Acting Insulin Biosimilar Increases Access to Insulin Therapy

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FDA’s approval of Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) provides an additional treatment option for adults and pediatric patients with diabetes mellitus. Insulin-aspart-szjj was approved in February 2025 for improving glycemic control in these patients.

Insulin-aspart-szjj is a rapid-acting human insulin analog and is the first rapid-acting insulin biosimilar product approved by FDA, the agency announced in a Feb. 14, 2025 press release (1). The biosimilar helps lower mealtime blood sugar spikes, which improves control of blood sugar in diabetes patients. The approval applies to both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.

Insulin-aspart-szjj (brand name Merilog, Sanofi) marks the third insulin biosimilar product approved by FDA. The two earlier biosimilar products were long-acting insulin biosimilar products, which were approved in 2021.

“[FDA] has now approved three biosimilar insulin products to treat diabetes,” said Peter Stein, MD, director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER), in the agency press release (1). “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, [such as] insulin. Increasing access to safe, effective, and high-quality medications at potentially lower cost remains a continued priority for [FDA].”

Similar to the reference biologic, insulin aspart (Novolog, Novo Nordisk), insulin-aspart-szjj should be administered within five to ten minutes prior to the start of a meal. It is administered subcutaneously by injection into the stomach, buttocks, thighs, or upper arms with dosing individualized and adjusted based on the patient’s needs.

In the United States, more than 38 million people have been diagnosed with diabetes. Approximately 8.4 million of these patients in the US rely on either rapid-acting and/or long-acting insulin therapy to manage diabetes, according to the FDA release.

“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 CDER.

FDA granted the approval to Sanofi-Aventis US LLC.

The global insulin market is projected to reach $23.21 billion by 2030, reflecting a compound annual growth rate of 3.7% from 2025 to 2030, according to a new market research report (2). In 2024, the long-acting insulin segment accounted for 52.4% of market revenues, while analog insulin accounted for 87.3% of revenue share 2024 based on its advantages over human insulin, the report said (2).

Growth of the global insulin market will be primarily driven by the increasing prevalence of diabetes and formulation advancements in insulin delivery. For example, in December 2019, FDA authorized Tandem Diabetes Care’s Control-IQ, an interoperable device, for marketing in the US. The Control-IQ is an automated insulin delivery (AID) algorithm that can be used with other interoperable devices (2,3). Following that, Tandem received authorization from FDA in February 2025 for its next-generation AID algorithm, Control-IQ+, for adults with type 2 diabetes (the device was already cleared for use by people with type 1 diabetes) (4). This next-generation device is expected to be available for in the US in March 2025.

References

1. FDA. FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes. Press Release. Feb. 14, 2025.
2. Grand View Research. Insulin Market Size, Share & Trends Analysis Report By Product (Rapid-Acting Insulin, Long-Acting Insulin, Combination Insulin, Biosimilar), By Application, By Type, By Distribution Channel, By Region, And Segment Forecasts, 2025 – 2030. Market Research Report. grandviewresearch.com, December 2024.
3. Tandem Diabetes Care. Tandem Diabetes Care Announces FDA Clearance of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology. Press Release. Dec. 13, 2019.
4. Tandem Diabetes Care. Tandem Diabetes Care Announces FDA Clearance of Control-IQ+ Automated Insulin Delivery Technology for People with Type 2 Diabetes. Press Release. Feb. 25, 2025.