Sanofi's Merilog Approved as First Rapid-Acting Insulin Biosimilar, Shaking Up Diabetes Market

The FDA has granted approval to Sanofi's Merilog (insulin-aspart-szjj), marking a significant milestone as the first-ever rapid-acting biosimilar insulin and the third insulin biosimilar to receive FDA clearance. This development comes amid a challenging landscape for the insulin market, which has faced pricing pressures and potential competition from emerging therapies.

Merilog Approval and Market Impact

Merilog, a biosimilar to Novo Nordisk's NovoLog, is indicated to control blood sugar levels in diabetes patients by managing mealtime glucose spikes. The FDA's approval covers both the 3-mL prefilled pen and 10-mL multiple-dose vial formulations of Merilog.

Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA's Center for Drug Evaluation and Research, emphasized the potential impact of this approval, stating that Merilog "can truly make a difference" for the millions relying on daily insulin injections. Yim noted that biosimilars can "increase access to these life-saving medications."

Insulin Market Challenges and Price Reductions

The approval of Merilog comes at a crucial time for the insulin market, which has faced significant challenges over the past year:

1. In March 2023, Sen. Bernie Sanders (I-Vt) called on Sanofi and Novo Nordisk to reduce insulin prices, following Eli Lilly's announcement of steep price cuts for its insulin products Humalog and Humulin.

2. Responding to this pressure, Novo Nordisk and Sanofi announced price reductions of up to 75% and 78%, respectively, for many of their insulin products.

3. Later in 2023, Novo Nordisk discontinued Levemir, a long-acting insulin, in the U.S. market, with the product being fully phased out by the end of 2024.

Potential Impact of GLP-1 Therapies

The rise of GLP-1 therapies presents a potential threat to the insulin market by indirectly addressing diabetes through obesity treatment. However, industry analysts remain divided on the extent of this impact:

Evan Seigerman, an analyst at BMO Capital Markets, suggested in a May 2024 interview that GLP-1s could lower rates of obesity and diabetes, potentially affecting insulin demand. Nevertheless, Seigerman believes that the immediate challenges facing the insulin market, such as price caps and reimbursement issues, are more pressing concerns for insulin developers than the growth of the GLP-1 market.

As the pharmaceutical industry continues to evolve, the approval of Merilog represents a significant development in the diabetes treatment landscape, potentially increasing access to vital medications while navigating a complex market environment.