FDA Approves Merilog: What It Means for the Diabetes Biosimilar Market

The U.S. Food and Drug Administration (FDA) has approved Merilog (insulin aspart-szjj), a biosimilar to NovoLog (insulin aspart), marking a significant expansion in diabetes treatment options. Developed by Meitheal Pharmaceuticals and Tonghua Dongbao Pharmaceutical, Merilog aims to enhance insulin accessibility and affordability for millions of Americans living with diabetes.

FDA Expands Insulin Options with Merilog Approval

This approval falls under the Biologics Price Competition and Innovation Act (BPCIA), which encourages competition by allowing biosimilars to enter the market. Biosimilars offer clinically equivalent alternatives to brand-name biologics but at lower costs. 

The FDA approval was based on the 6-month, phase 3 GEMELLI 1 study (NCT03211858), which evaluated Merilog (SAR341402) versus originator insulin aspart in 597 patients with type 1 or type 2 diabetes using multiple daily injections with insulin glargine. At week 26, Merilog demonstrated noninferior HbA1c reduction (–0.38% vs. –0.30%), with comparable fasting plasma glucose, postprandial glucose, insulin dosages, immunogenicity, and hypoglycemia rates. The biosimilar provided effective glycemic control with a similar safety profile to the reference product.  

According to the American Diabetes Association, 38.4 million Americans—11.6% of the population—had diabetes in 2021. This includes 2 million people with type 1 diabetes, among them approximately 304,000 children and adolescents. Hence, access to affordable insulin remains a public health priority, bordering on a health emergency.

Merilog’s approval aligns with ongoing efforts to lower insulin prices. Since 2023, major insulin producers, including Novo Nordisk, Eli Lilly, and Sanofi, have cut insulin costs due to policy changes and pressure from lawmakers. Now, Merilog’s entry strengthens competition and could further drive down prices for patients reliant on rapid-acting insulin.

A Look at the Diabetes Landscape

The World Health Organization (WHO) reports that global diabetes cases increased from 200 million in 1990 to 830 million in 2022. Low- and middle-income countries have experienced a faster rise in diabetes cases than high-income nations. In 2022, an estimated 14% of adults had diabetes, with 59% not receiving medication for treatment. Complications from diabetes caused 1.6 million deaths in 2021, with 47% occurring in people under 70.

The International Diabetes Federation (IDF) projects that 783 million adults will have diabetes by 2045, a 46% increase from 2021. Urbanization, aging populations, reduced physical activity, and rising obesity rates contribute to this trend. Africa faces the highest increase, with cases expected to grow by 134%.

Type 2 diabetes accounts for 90% of all cases worldwide. Once common in older adults, it is now rising in children and young adults. Poor diets and increasing obesity rates drive this shift. In 2022, approximately 8.75 million people were diagnosed with Type 1 diabetes.

Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the FDA’s Center for Drug Evaluation and Research, emphasized the importance of biosimilar insulin options in a news release, stating, “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.”

The Growing Biosimilar Insulin Market

Merilog joins a growing list of biosimilar insulins, providing additional choices for diabetes patients and healthcare providers. The biosimilar insulin market already includes Rezvoglar (insulin glargine-aglr) and Basaglar (insulin glargine), both biosimilars of Lantus, manufactured by Eli Lilly. Semglee (insulin glargine-yfgn), developed by Biocon and Viatris, remains the first and only interchangeable biosimilar insulin, meaning pharmacists can substitute it for Lantus without physician approval.

While biosimilars promise affordability, adoption remains slow due to multiple challenges. Unlike generic drugs, biosimilars require extensive testing to demonstrate similarity to reference biologics, increasing development costs. Additionally, pricing negotiations with insurers and pharmacy benefit managers influence market penetration. Some physicians hesitate to switch patients from well-established brands due to concerns about insurance coverage and potential differences in formulation, even when biosimilars are proven to be equally effective.

The FDA continues efforts to streamline biosimilar approvals, aiming to accelerate competition. Market analysts predict that an increasing number of biosimilar insulins could reshape diabetes treatment pricing over the next decade, making it more sustainable for patients and healthcare systems alike.

Market Trends and Competitive Landscape

The biosimilar insulin market is expanding rapidly as patent protections on biologic insulins expire, opening the door for new competition. Sanofi, traditionally known for producing Lantus, has introduced Insulin Aspart Sanofi, a biosimilar to Novo Nordisk’s NovoLog. Eli Lilly continues to position itself as a leader in biosimilar insulin production, leveraging its manufacturing capabilities to reduce costs and capture market share. New entrants, including Gan & Lee Pharmaceuticals, are expanding biosimilar offerings, particularly in emerging markets.

The growing competition is driving aggressive pricing strategies among manufacturers. Biosimilar developers are working to establish agreements with insurance providers and government programs to facilitate greater adoption. Some European countries have already implemented policies favoring biosimilars, incentivizing their use in place of costlier reference biologics. The U.S. market is slowly following suit, though regulatory hurdles and provider hesitancy remain significant barriers.

Despite these challenges, biosimilar insulins continue gaining traction. The Biden administration’s Inflation Reduction Act capped insulin prices at $35 per month for Medicare beneficiaries, but many uninsured and privately insured patients still face high costs. Expanding biosimilar adoption could create broader price reductions across all patient groups, benefiting both individuals and healthcare systems.

Combining Forces: Biosimilars and Advanced Drug Delivery for Next-Level Therapies

The diabetes treatment landscape is evolving beyond traditional insulin therapies, with biosimilars playing an increasingly important role in innovation. Researchers are developing next-generation biosimilars with improved properties, such as ultra-rapid-acting insulins and long-acting insulin analogs. These advancements aim to enhance glycemic control, reduce injection frequency, and improve patient adherence.

In addition, biosimilar developers are exploring combination therapies that integrate biosimilars with advanced drug delivery technologies. Pairing insulin biosimilars with continuous glucose monitoring (CGM) systems and smart insulin pens enhances treatment precision by providing real-time glucose data and personalized dosing recommendations. Such innovations could revolutionize diabetes care by optimizing outcomes and simplifying disease management.

Researchers are also investigating alternative insulin delivery methods, including oral and inhalable biosimilars. While challenges such as bioavailability and stability remain, ongoing clinical trials show promising potential. If successful, these new formulations could reduce reliance on injections and improve patient compliance. Merilog is administered subcutaneously in the abdomen, buttocks, thighs, or upper arms within 5 to 10 minutes before meals, similar to Novolog. Dosage is individualized based on patient needs.

Looking ahead, the combination of increasing biosimilar availability, policy support, and continuous research efforts will shape the future of diabetes care. Biosimilars will not only help lower treatment costs but also contribute to advancements in drug efficacy and delivery, ultimately improving quality of life for millions of people with diabetes worldwide.

Expanding Biosimilar Adoption: A Key to Lower Prices for All Patients

Despite increasing biosimilar approvals, patient adoption faces hurdles. Many healthcare providers hesitate to switch patients from established brands due to concerns about insurance coverage and physician preference. Additionally, pharmacy chains often lack incentives to stock biosimilars over branded insulins.

Regulatory policies continue evolving to address these barriers. The Biden administration’s Inflation Reduction Act capped insulin prices at $35 per month for Medicare beneficiaries, but many uninsured and privately insured patients still struggle with high costs. Industry stakeholders argue that expanding biosimilar adoption could drive broader price reductions across all patient groups.

Looking ahead, analysts expect further biosimilar developments. Companies like Biocon, Samsung Bioepis, and Gan & Lee Pharmaceuticals are advancing new biosimilar insulin candidates. As more products enter the market, competition will likely intensify, pressuring brand-name manufacturers to maintain competitive pricing.

Merilog’s approval represents progress toward a more competitive insulin market. While challenges remain, continued biosimilar development and policy support could transform diabetes care affordability, ensuring millions of Americans have better access to life-saving treatments.

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Author

Bernice Lottering