Sandoz has announced that the European Commission has granted marketing authorization for Ranluspec® (ranibizumab), a biosimilar developed by Lupin. The approval marks a significant step in expanding access to advanced ophthalmic therapies across Europe.
Ranluspec is approved for the treatment of neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, macular edema following retinal vein occlusion, and choroidal neovascularization. The authorization was supported by a comprehensive clinical and analytical data package demonstrating equivalent efficacy and comparable safety to the reference product, Lucentis.
Retinal disorders continue to pose a major public health challenge. An estimated four million people across France, Germany, Italy, Spain, the UK, the US and Japan are living with nAMD. In Europe alone, between 20% and 35% of individuals with diabetes are expected to develop diabetic retinopathy during their lifetime. With this approval, Sandoz aims to improve affordability and patient access to biologic eye therapies, with launch anticipated in the second half of 2026.
Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, stated that retinal diseases create a substantial burden for patients and healthcare systems alike. She noted that the authorization of Ranluspec reinforces the company’s commitment to delivering high-quality biosimilars and widening access to life-changing treatments across Europe.
The approval further strengthens Sandoz’s leadership in biosimilars, a journey that began with the introduction of Omnitrope in 2006. It also builds on the company’s expanding ophthalmology portfolio, following the European launch of Afqlir in 2025. Sandoz views ophthalmology as a strategic growth area within a projected global biosimilars market opportunity estimated at approximately USD 320 billion over the next decade.
Under a commercial partnership announced in August 2025, Sandoz holds exclusive commercialization rights for Ranluspec across the European Union, excluding Germany, and semi-exclusive rights in France. In Germany, Sandoz markets ranibizumab under the brand Epruvy through a separate agreement.
With regulatory clearance now secured, Ranluspec is positioned to broaden treatment options for patients with serious retinal vascular conditions, supporting more sustainable healthcare delivery across Europe.
