European Commission Grants Approval To Sandoz’s Ranluspec Ranibizumab Biosimilar For Retinal Diseases, Expands Ophthalmology Portfolio

Sandoz announced that the European Commission has granted marketing authorisation for Ranluspec, a ranibizumab biosimilar developed, manufactured and registered by Lupin. The approval follows the review of a comprehensive clinical and analytical data package demonstrating equivalent efficacy and comparable safety to the reference medicine, Lucentis® (ranibizumab).

Ranluspec is approved for multiple ophthalmic indications, including neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, macular edema secondary to retinal vein occlusion, and choroidal neovascularisation. These conditions represent a significant disease burden globally, with millions affected by nAMD and a substantial proportion of people with diabetes in Europe developing diabetic retinopathy.

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.”

The authorization supports an anticipated European launch of Ranluspec in the second half of 2026. The approval further strengthens Sandoz’s leadership in biosimilars, building on its legacy since launching Omnitrope® (somatropin) in 2006. It also expands the company’s ophthalmology portfolio, following the 2025 European launch of Afqlir® (aflibercept), and aligns with its strategy to capture a share of the projected USD 320 billion biosimilar market opportunity over the next decade.

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