European Commission Authorizes Ranluspec Strengthening Sandoz Ophthalmology Portfolio and Biosimilar Strategy

European Commission Authorizes Ranluspec Strengthening Sandoz Ophthalmology Portfolio and Biosimilar Strategy

(IN BRIEF) The European Commission has approved Ranluspec, a ranibizumab biosimilar developed by Lupin and commercialized by Sandoz, for the treatment of neovascular age-related macular degeneration and several other retinal disorders. The therapy has demonstrated comparable efficacy and safety to its reference medicine and is expected to launch in Europe in the second half of 2026. The approval addresses a significant patient population affected by retinal diseases and reinforces Sandoz’s strategy to expand its biosimilars and ophthalmology portfolio through partnerships and increased access to affordable therapies.

(PRESS RELEASE) BASEL, 24-Nov-2025 — /EuropaWire/ — Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, has announced that the European Commission has granted marketing authorization for Ranluspec¹, a biosimilar developed by Lupin for the treatment of several serious retinal diseases, including neovascular (wet) age-related macular degeneration (nAMD). The approval follows evaluation of an extensive clinical and analytical data package supporting the medicine’s efficacy, safety, and comparability to its reference therapy, Lucentis®².

Ranluspec is indicated for a range of vision-threatening conditions, including visual impairment associated with diabetic macular edema, proliferative diabetic retinopathy, macular edema resulting from retinal vein occlusion, and choroidal neovascularization. The therapy has demonstrated equivalent therapeutic performance and a comparable safety profile to the reference product, supporting its use as an alternative treatment option.

The decision comes amid significant unmet need in ophthalmology. An estimated four million people across major global markets live with neovascular age-related macular degeneration³, while between 20 percent and 35 percent of individuals with diabetes in Europe are expected to develop diabetic retinopathy⁴. The availability of a biosimilar is expected to improve access to treatment for these conditions by broadening availability and supporting healthcare system sustainability. Launch of Ranluspec in Europe is anticipated in the second half of 2026.

The authorization further strengthens Sandoz’s position in the biosimilars sector and expands its ophthalmology portfolio, building on earlier developments such as the European introduction of Afqlir (aflibercept) in 2025. The milestone aligns with the company’s broader strategy to capture growth opportunities in a biosimilars market projected to expand significantly over the coming decade⁵.

Sandoz and Lupin entered into a commercial partnership in August 2025 covering development and commercialization of the ranibizumab biosimilar. Under the agreement, Sandoz holds exclusive commercialization rights for Ranluspec across the European Union, with the exception of Germany, and semi-exclusive rights in France. In Germany, Sandoz markets a ranibizumab product under a separate arrangement.

The approval represents another step in expanding the availability of biosimilar medicines aimed at increasing treatment access while maintaining high standards of quality and clinical performance.

* Lucentis® is a registered trademark of Genentech Inc.

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). 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 (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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SOURCE: Sandoz