The European Commission has granted marketing authorization for Ranluspec® (ranibizumab), a biosimilar intended to treat several retinal vascular disorders. Sandoz confirmed the approval and said the product was developed, manufactured and registered by Lupin, based on 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. According to Sandoz, Ranluspec has equivalent efficacy and comparable safety to its reference medicine, Lucentis® (ranibizumab).
An estimated four million people are affected by neovascular age-related macular degeneration across France, Germany, Italy, Spain, the United Kingdom, the United States and Japan. In Europe, between 20% and 35% of people with diabetes are expected to develop diabetic retinopathy. Sandoz said the approval paves the way for an expected launch of Ranluspec in the second half of 2026, with the potential to expand access to treatment for European patients.
Sandoz stated that the decision reinforces its strategy in biosimilars and ophthalmology, following its first biosimilar, Omnitrope® (somatropin), introduced in 2006, and the 2025 European launch of Afqlir® (aflibercept). The company said it aims to capitalize on a projected biosimilar market opportunity of about USD 320 billion over the next 10 years.
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 is commercializing Epruvy® (ranibizumab) under a separate agreement.
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