Sandoz confirms European Commission approval of Ondibta® (insulin glargine), strengthening overall biosimilars leadership and position in diabetes

• Biosimilar Ondibta^® (insulin glargine) approved for treatment of diabetes mellitus across all indications of reference medicine
• Expected launch by early 2027; potential to expand access to insulin treatment option for tens of millions of European patients
• Strengthens Sandoz position in diabetes; reinforces commitment to helping patients access critical and potentially life-changing biologic medicines

Basel, January 14, 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the 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.

Ondibta^® is approved for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above¹ and is confirmed to match the reference medicine, Lantus^® SoloStar^®* insulin pen, in terms of safety, quality and efficacy². 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.

Claire D’Abreu-Hayling, Chief Scientific Officer, 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.”

Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin, a hormone that regulates blood glucose, or when the body cannot effectively use the insulin that it produces. It can cause blindness, kidney failure, heart attacks, stroke and lower limb amputation³. According to latest estimates, there are 66 million adults aged 20-79 living with diabetes in Europe⁴, a figure that is expected to increase 10% by 2050 to 72 million⁵, with related healthcare expenditure approaching USD 200 billion⁶.

Sandoz entered into an agreement with Gan & Lee in December 2018 to commercialize biosimilar versions of the insulins glargine, lispro and aspart. Under the terms of the agreement, Sandoz will commercialize in Europe and other key territories around the world, while Gan & Lee is responsible for development, registration, manufacturing and supply.

The approval builds on the continuing Sandoz leadership and pioneering legacy in biosimilars, dating back to the introduction of the first biosimilar in 2006. It also strengthens the Sandoz position in diabetes, while representing another step towards the overall strategic objective of capitalizing on a projected ~USD 320 billion biosimilar-market opportunity over the next 10 years⁷.

Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 13 biosimilars and a further 27 assets in various stages of development.

*Lantus^® and SoloStar^® are registered trademarks of Sanofi-Aventis Deutschland GmbH.

About Ondibta^® (insulin glargine)

Insulin glargine is a long-acting basal insulin analog administered once daily. It has a smooth, peakless, predictable concentration with a prolonged duration of action lasting up to 24 hours, ensuring consistent blood glucose control with proven efficacy and safety. Therefore, insulin glargine injection has become an especially important basal insulin analog in the treatment of diabetes^1,2.

DISCLAIMER

This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

REFERENCES

¹ European Medicines Agency (EMA). Ondibta^® (insulin glargine): Product details. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/ondibta#product-details [Last accessed: January 2026].

² European Medicines Agency (EMA). Lantus^® (insulin glargine): Prescribing Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/lantus  [Last accessed: January 2026].

³ World Health Organization. Diabetes Factsheet. Available at: Diabetes [Last accessed: January 2026].

⁴ IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/ [Last accessed: January 2026].

⁵ IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/ [Last accessed: January 2026].

⁶ IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/ [Last accessed: January 2026].

⁷ Covers US and EU markets (2026–2035). Originator sales and LoE based on internal analysis of data from multiple subscription databases. Biosimilar data accessed in September 2025.

ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.  

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