India Pharma Outlook Team | Tuesday, 24 February 2026
Lupin biosimilar ranibizumab approval has just been secured from the European Commission, marking a major win for the global pharma firm.
The nod follows a positive opinion from the Committee for Medicinal Products for Human Use and clears the way for Lupin’s Ranluspec in both vials and pre?filled syringes across the European Union (EU).
Ranibizumab is a well?known treatment that blocks vascular endothelial growth factor A. It’s widely used to treat serious eye conditions, including neovascular (wet) age?related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization. With this approval, Lupin’s biosimilar version will expand options for patients who rely on these advanced therapies.
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Thierry Volle, president of EMEA and Emerging Markets at Lupin, said, “We are very pleased to receive the European Commission approval for ranibizumab. This achievement underscores the strength and quality of our scientific capabilities and manufacturing excellence. We remain firmly committed to expanding access to innovative, high?quality, and affordable biologic therapies for underserved patients worldwide.”
Dr. Cyrus Karkaria, president of biotechnology at Lupin, added, “The approval from the European Commission for our biosimilar ranibizumab is a milestone that validates our unwavering commitment and scientific standards to making advanced biologic therapies more accessible.”
In the EU, Sandoz will commercialize the product outside Germany. In France, Lupin has partnered with both Sandoz and Biogaran to bring Ranluspec to patients. This strategic rollout aims to boost access to a critical eye care therapy at more affordable prices.
