Cardiovascular Business February 20, 2025
The U.S. Food and Drug Administration (FDA) has approved a new biosimilar substitute for Novo Nordisk’s NovoLog, the rapid-acting insulin product used to treat adult and pediatric patients with type 1 and type 2 diabetes. It is the first rapid-acting insulin biosimilar, and third insulin biomarker overall, to gain FDA approval.
Insulin-aspart-szii is being sold by Sanofi-Aventis U.S. under the brand name Merilog. It is available as a 3-mL prefilled pen and as a 10-mL multiple-dose vial. This is the first rapid-acting insulin biosimilar, and third insulin biomarker overall, to gain FDA approval.
“The FDA has now approved three biosimilar insulin products to treat diabetes,” Peter Stein, MD, director of the Office of New Drugs in the FDA’s...
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