Sandoz Receives European Commission Approval for Ondibta Insulin Glargine

Reuters01-14
Sandoz Receives European Commission Approval for Ondibta Insulin Glargine

Sandoz Group AG has received marketing authorization from the European Commission for Ondibta® (insulin glargine), a biosimilar 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 above, with demonstrated equivalence to the reference medicine, Lantus® SoloStar®, in terms of safety, quality, and efficacy. The product is expected to launch by early 2027, with the potential to expand access to insulin treatment options for patients across Europe. Under a commercialization agreement, Sandoz will market Ondibta® in Europe and other key territories, while Gan & Lee is responsible for development, registration, manufacturing, and supply.

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