Sandoz confirmed that the European Commission has granted marketing authorization for Ondibta® (insulin glargine), a solution for injection in a pre-filled pen developed and registered by Gan & Lee Pharmaceuticals.
Ondibta® is approved for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above1 and is confirmed to match the reference medicine, Lantus® SoloStar®* insulin pen, in terms of safety, quality and efficacy2. The approval paves the way for an expected launch of Ondibta® by early 2027, which has the potential to increase competition, improve affordability and enhance access to insulin treatment options for people living with diabetes in Europe.
Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: “Diabetes remains one of the fastest-growing global health challenges, placing a significant burden on tens of millions of patients across Europe, their families and healthcare systems. The approval of Ondibta® marks an important milestone in addressing this need and underscores our commitment to improving patient access to critical, potentially life-changing biologic medicines.”
Sandoz entered into an agreement with Gan & Lee in December 2018 to commercialize biosimilar versions of the insulins glargine, lispro and aspart. Under the terms of the agreement, Sandoz will commercialize in Europe and other key territories around the world, while Gan & Lee is responsible for development, registration, manufacturing and supply.
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