Sandoz Confirms European Commission Approval For Ranluspec (ranibizumab), Further Strengthening Overall Biosimilars Leadership And Position In Ophthalmology

• Biosimilar Ranluspec approved by European Commission for treatment of neovascular (wet) age-related macular degeneration (nAMD) and other retinal vascular disorders
• Around four million people across key global markets live with nAMD; between 20% and 35% of people with diabetes in Europe will develop diabetic retinopathy
• Launch expected second half of 2026; potential to expand access to life-changing treatment option for European patients

Sandoz, the global leader in affordable medicines, today confirmed that the European Commission has granted marketing authorization for Ranluspec¹. Ranluspec is developed, manufactured and registered by Lupin and was approved based on the review of a comprehensive data package.

Ranluspec is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization. Ranluspec has equivalent efficacy and comparable safety to its reference medicine, Lucentis^*2.

Around four million people are estimated to have neovascular age-related macular degeneration in France, Germany, Italy, Spain, the UK, the US and Japan³, and between 20% and 35% of people with diabetes in Europe will develop diabetic retinopathy⁴. The approval paves the way for an expected launch of Ranluspec in the second half of 2026.

Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: “Retinal diseases, including nAMD, place a significant burden on millions of patients, families and caregivers in Europe. The approval of Ranluspec reinforces our commitment to expanding the availability of high‑quality biosimilars and transforming healthcare by ensuring that patients can access these life‑changing treatments.”

Today’s announcement builds on the continuing leadership and pioneering legacy Sandoz has established in biosimilars, which began with the introduction of the first biosimilar, Omnitrope (somatropin), in 2006. It strengthens the company’s position in ophthalmology, following the launch of Afqlir (aflibercept) in Europe in 2025 and also represents another step towards the overall Sandoz strategic objective of capitalizing on a projected ~USD 320 billion biosimilar-market opportunity over the next 10 years⁵.

Sandoz and Lupin announced a commercial partnership in August 2025 for the development and commercialization of a ranibizumab biosimilar. Under the terms of the agreement, Sandoz holds exclusive commercialization rights for Ranluspec across the European Union, excluding Germany, and semi-exclusive rights in France. Sandoz is commercializing Epruvy (ranibizumab) in Germany under a separate agreement.

^* Lucentis is a registered trademark of Genentech Inc.

References
¹ European Medicines Agency (EMA). Ranluspec (ranibizumab): Product Details. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/ranluspec [Last accessed: February 2026]

² European Medicines Agency (EMA). Lucentis (ranibizumab): Prescribing Information. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/lucentis [Last accessed: February 2026]

³ DRG Clarivate Landscape and Forecast. Dry and Wet Age-Related Macular Degeneration. Report December 2024

⁴ Eye disease (2024) IDF Europe Site. Available at: https://idf.org/europe/life-with-diabetes/diabetes-related-complications/eye-disease/ [Last accessed: February 2026]

⁵ 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 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.