On 14 January 2026, Sandoz announced that the European Commission has approved Ondibta® (insulin glargine solution for injection in pre-filled pen), biosimilar to Sanofi’s Lantus® Solostar®. Ondibta® is registered in Europe by Gan & Lee Pharmaceuticals and received a positive recommendation from the EMA’s CHMP in November 2025.
Sandoz expects to launch Ondibta® in Europe by early 2027. The product is approved for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.
Sandoz and Gan & Lee partnered in December 2018 in relation to the commercialisation of insulin glargine, insulin lispro and insulin aspart biosimilars. Under the agreement, Sandoz is responsible for commercialising the products in Europe and other key territories, while Gan & Lee has responsibility for development, registration, manufacturing and supply.
Insulin glargine biosimilars have been approved in Europe since 2014 (the first was Eli Lilly’s Abasaglar®).