Sandoz Group AG (SDZ.SW) announced that the European Commission has approved Ondibta (insulin glargine), a biosimilar to Sanofi's Lantus SoloStar, for the treatment of diabetes mellitus across all indications of the reference medicine.
Why This Matters for Diabetes Care
Diabetes mellitus is a chronic condition affecting millions worldwide. Insulin glargine, a long-acting insulin analogue, helps patients maintain stable blood glucose levels. Ondibta offers a lower-cost alternative, expanding access to treatment and reducing healthcare costs.
Clinical Equivalence Confirmed
The approval follows a comprehensive review of analytical and clinical data demonstrating that Ondibta is comparable in safety, efficacy, and quality with Lantus. Developed in partnership with Gan & Lee Pharmaceuticals, Ondibta is approved for adults, adolescents, and children aged two years and older.
Global Expansion Potential
Ondibta has not yet been approved in the United States, but Sandoz has indicated that regulatory filings in other markets are under consideration. The company already markets a broad biosimilars portfolio globally, with diabetes care now strengthening its pipeline.
Revenue Contribution from Biosimilars
Sandoz has reported steady revenue growth from its biosimilars division, which has become a key driver of overall group sales. Biosimilars contributed significantly to Sandoz's group sales in 2025, and Ondibta is expected to add to this momentum once launched in Europe, with commercial rollout anticipated by early 2027.
SDZ.SW has traded between CHF 26.25 and CHF 61.18 over the past year. The stock is currently trading at CHF 60.88, up 2.77%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.