Merilog’s approval comes as the insulin space has over the past year suffered several setbacks, including strong calls for price caps and, potentially, the rise of the mammoth GLP-1 market.
The FDA on Friday cleared Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novo Nordisk’s rapid-acting insulin NovoLog.
Like its branded reference counterpart, Merilog is indicated to lower spikes in blood sugar concentrations during meals and help control glucose levels in patients with diabetes, according to the FDA’s announcement of the approval. Friday’s regulatory go-ahead covers both the 3-mL prefilled pen of Merilog and its 10-mL multiple-dose vial.
Merilog is the first-ever rapid-acting biosimilar and the third insulin biosimilar approved by the FDA, the agency noted.
Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA’s Center for Drug Evaluation and Research, said in a statement that Merilog’s approval “can truly make a difference” for the “millions of people who rely on daily injections of insulin” for their diabetes. A biosimilar, she said, can “increase access to these life-saving medications.”
Merilog’s approval could serve to reinvigorate a battered insulin market, which over the past year has endured strong headwinds.
In March 2023, Sanofi and Novo came under fire from Sen. Bernie Sanders (I-Vt), who asked the companies to follow in the footsteps of fellow diabetes leader Eli Lilly and lower the price of their insulin products. Lilly had announced steep price cuts at the time, planning a 70% reduction in cost for Humalog and Humulin—both short-acting insulin products—and capping patients’ out-of-pocket at $35 per month.
Novo and Sanofi agreed a few days later, announcing price reductions of up to 75% and 78% for many of their insulin products, respectively. Later that year, in November, Novo announced that it would discontinue Levemir, a long-acting insulin, in the U.S. The pharma at the time said it would “continue to provide Levemir … while supplies last.” The brand was fully discontinued at the end of 2024.
The meteoric rise of GLP-1 therapies may also pose a threat to the insulin market by indirectly addressing diabetes through obesity, though analysts continue to be mixed on the matter. In a May 2024 interview with BioSpace, BMO Capital Markets analyst Evan Seigerman said that GLP-1s could lower rates of obesity and diabetes, in turn potentially affecting the demand for insulin.
Still, Seigerman believes that the strength of the GLP-1 space remains, at least currently, a separate issue from the problems facing the insulin market. Price caps and reimbursements, along with other cost considerations for insulin developers, are more pressing matters, he said.
