Sandoz confirms EC approval of Ondibta biosimilar

Switzerland-based Sandoz (SIX: SDZ), a global leader in affordable medicines, today 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. Sandoz shares were up 3.9% at 61.56 francs by late afternoon.

Ondibta is approved for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above and is confirmed to match the reference medicine, French pharma major Sanofi’s (Euronext: SAN) Lantus SoloStar insulin pen, in terms of safety, quality and efficacy. Lantus SoloStar sales are projected to reach 2.5 billion euros ($2.9 billion) for full-year 2025

Tsandoz noted that 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.