FDA approves Merilog, first NovoLog biosimilar for diabetes

FDA’s commitment to expanding biosimilar access

Peter Stein, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, emphasized the agency's dedication to increasing biosimilar approvals and fostering a competitive insulin market in an FDA news release.

"The FDA has now approved three biosimilar insulin products to treat diabetes," Stein said in the news release. "Today's approval highlights our ongoing efforts to streamline the biosimilar approval process, support market competition and expand options for costly treatments like insulin. Increasing access to safe, effective and high-quality medications at a potentially lower cost remains a top priority."

Implications for patients and healthcare costs

For patients managing diabetes, the introduction of a rapid-acting insulin biosimilar could offer a more affordable treatment alternative. Unlike generic drugs, biosimilars must demonstrate no clinically meaningful differences in safety, purity and potency compared to their reference products. With the approval of Merilog, patients now have an additional option that meets these rigorous standards.

Insulin affordability has been a longstanding issue, with U.S. insulin prices significantly higher than in other developed nations. According to a 2022 Rand Corporation study, the average price of insulin in the U.S. was over ten times higher than in 32 other high-income countries, with some patients paying up to $1,000 per month out-of-pocket for their medication. Additionally, CDC data estimates that 38.4 million people of all ages, or roughly 11.6% of the U.S. population, had diabetes in 2021.

"For the millions of people who rely on daily insulin injections, having a biosimilar option for rapid-acting insulin could be transformative, as these products have the potential to improve accessibility to life-saving medications," Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA, detailed in the news release.

Challenges and market considerations

Despite the potential benefits, biosimilar insulins have historically faced barriers to widespread adoption, including provider awareness, insurance coverage and patient acceptance. The insulin market has long been dominated by a few manufacturers, with high prices sparking policy debates and legislative efforts to reduce costs. The introduction of Merilog will be closely watched to see whether it leads to meaningful price reductions or encounters market challenges similar to those of previous biosimilars.

Industry experts suggest that policies encouraging the use of interchangeable biosimilars and broader insurance reimbursement could play a crucial role in determining Merilog's impact. Additionally, Sanofi's ability to secure formulary placements and educate providers on biosimilar benefits will influence its commercial success.

Merilog's approval represents a major step toward expanding the biosimilar insulin market, promoting competition and increasing access to vital diabetes treatments. As the FDA remains focused on advancing biosimilar development, stakeholders must adapt to shifting dynamics in pricing, market adoption and long-term cost savings.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.