Sandoz wins EC nod for two insulin biosimilars

Swiss drugmaker Sandoz (SIX: SDZ) today confirmed that the European Commission has granted marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, are developed by Gan & Lee Pharmaceuticals.

Bysumlog is approved for the treatment and initial stabilization of diabetes mellitus in adults and children, while Dazparda is approved for the treatment of diabetes mellitus in adults, adolescents and children aged one year or more. Both biosimilar insulins have equivalent efficacy and comparable safety to their respective reference medicines, Eli Lilly’s (NYSE: LLY), Humalog and Novo Nordisk’s (NOV: N) NovoRapid. Following these approvals, Bysumlog and Dazparda have the potential to increase competition, improve affordability and expand access to insulin treatment options for millions of people living with diabetes across Europe, said Sandoz.