Lupin receives European Commission approval for Biosimilar Ranibizumab

New Delhi: Global pharma major Lupin Limited has received the approval from European Commission for its biosimilar ranibizumab, Ranluspec^TM (for vials and pre-filled syringes), following the recent positive opinion from the Committee for Medicinal Products for Human Use.

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A. Its indications encompass the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization.

Thierry Volle, President EMEA and Emerging Markets, 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.”

“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,” said Dr. Cyrus Karkaria, President Biotechnology, Lupin.

Lupin’s biosimilar ranibizumab will be commercialized by Sandoz across the European Union (excluding Germany). In France, the product will be commercialized by two companies, Sandoz and Biogaran.