Sandoz confirms the EC granted marketing authorization for Bysumlog, Dazparda

Sandoz (SDZNY) confirms that the European Commission, EC, has granted marketing authorization for Bysumlog and Dazparda. 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. “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,” the company said.