Sandoz Secures European Commission Approval for Ondibta® (Insulin Glargine), Reinforcing Leadership in Biosimilars and Diabetes Care
Sandoz a global leader in affordable medicines, today announced that the European Commission has granted marketing authorization for Ondibta® (insulin glargine), a solution for injection delivered via a pre-filled pen developed and registered by Gan & Lee Pharmaceuticals. This approval marks a significant milestone in Sandoz’s ongoing commitment to expanding access to essential diabetes treatments in Europe.
Ondibta® is authorized for the treatment of diabetes mellitus in adults, adolescents, and children aged two years and older. Clinical evaluation has confirmed that Ondibta® is highly comparable to the reference medicine, Lantus® SoloStar®, in terms of safety, efficacy, and quality, ensuring patients receive the same therapeutic benefits as the established insulin therapy. The approval sets the stage for an anticipated market launch by early 2027, a development that is expected to increase competition, improve affordability, and enhance accessibility to insulin therapy for millions of people living with diabetes across Europe.
Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, emphasized the significance of this milestone, stating:
“Diabetes continues to be one of the fastest-growing health challenges globally, placing a significant burden on tens of millions of patients in Europe, as well as their families and healthcare systems. The approval of Ondibta® represents an important step toward addressing this pressing need and reflects our commitment to expanding patient access to critical, potentially life-changing biologic medicines.”
Diabetes is a chronic metabolic disorder that occurs either when the pancreas produces insufficient insulin, a hormone crucial for regulating blood glucose, or when the body cannot effectively use the insulin it produces. The disease can lead to severe complications, including blindness, kidney failure, cardiovascular events, stroke, and lower limb amputation. Recent estimates indicate that approximately 66 million adults aged 20–79 are living with diabetes in Europe, with this number projected to increase by 10% to 72 million by 2050. The associated healthcare costs are expected to approach USD 200 billion, underscoring the urgent need for affordable, effective treatments.
Sandoz has a long-standing collaboration with Gan & Lee Pharmaceuticals, dating back to December 2018, to commercialize biosimilar insulins glargine, lispro, and aspart. Under this partnership, Sandoz is responsible for commercialization in Europe and other key global markets, while Gan & Lee handles development, regulatory approval, manufacturing, and supply. This collaboration exemplifies a shared commitment to broadening access to affordable diabetes care worldwide.
The approval of Ondibta® reinforces Sandoz’s leadership and pioneering legacy in biosimilars, which began with the launch of the company’s first biosimilar in 2006. This milestone also strengthens Sandoz’s position in diabetes care and represents a strategic step toward capitalizing on a projected ~USD 320 billion global biosimilars market over the next decade. By expanding its portfolio of high-quality biosimilars, Sandoz aims to provide sustainable, cost-effective solutions for patients and healthcare systems facing growing demand for biologic therapies.
Currently, Sandoz offers a global portfolio of 13 approved biosimilars, with an additional 27 assets in various stages of development, underscoring the company’s ongoing commitment to improving patient access to essential medicines. Through these efforts, Sandoz seeks to reduce treatment costs and enable broader availability of biologic therapies for chronic conditions like diabetes.
About Ondibta® (Insulin Glargine)
Insulin glargine is a long-acting basal insulin analog administered once daily. It provides a smooth, peakless, and predictable insulin concentration with a prolonged duration of action lasting up to 24 hours. This ensures consistent blood glucose control, with demonstrated efficacy and safety, making insulin glargine an essential therapy for people managing diabetes. The availability of Ondibta® in a pre-filled pen format adds convenience and flexibility for patients, aligning with modern standards of diabetes care.
By introducing Ondibta® to the European market, Sandoz continues to deliver on its mission to enhance patient access to life-changing biologic medicines, strengthen competition in the insulin market, and support healthcare systems in managing the growing burden of diabetes.
Source link :https://www.sandoz.com/
