Sandoz’ Ondibta receives European Commission approval for diabetes
Esme Needham | January 26, 2026 | News story | Research and Development | Diabetes, Ondibta, Sandoz
Sandoz has announced that its Ondibta (insulin glargine) has received approval from the European Commission (EC) for the treatment of diabetes in adults, adolescents and children aged two years and older.
Ondibta is a biosimilar of Sanofi-Aventis’ Lantus SoloStar insulin pen; the EC’s approval confirms that Ondibta matches its reference product in safety, efficacy and quality, and can now be launched. The launch is expected by early 2027.
Diabetes is a chronic condition caused either by the pancreas’ inability to produce sufficient insulin or by the body’s inability to use its own insulin. There are an estimated 66 million adults aged 20-79 currently suffering from diabetes in Europe, and this figure will likely increase to 72 million by 2050. Serious complications from diabetes include blindness, kidney failure, heart attack, stroke and lower limb amputation.
A biosimilar of Lantus SoloStar could reduce both patient burden and strain on healthcare systems. Currently, diabetes-related healthcare expenses in Europe total almost $200bn.
The approval of Ondibta follows Sandoz’ 2018 agreement with Gan & Lee to commercialise biosimilars of multiple insulins: glargine, lispro and aspart. Gan & Lee is responsible for the development, registration, manufacture and supply of the insulins, while Sandoz is responsible for their European commercialisation.
Claire D’Abreu-Hayling, chief scientific officer at 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 is a global pharmaceutical company specialising in the development and production of biosimilar medicines.
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