Lupin receives European Commission approval for biosimilar ranibizumab RanluspecTM
Following positive CHMP opinion, Lupin to commercialise RanluspecTM in EU through Sandoz partnership
Global pharma major Lupin has announced that it has received approval from the European Commission for its biosimilar ranibizumab, RanluspecTM, for vials and pre-filled syringes. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use.
Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A. Its indications include the treatment of patients with neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, proliferative diabetic retinopathy, and choroidal neovascularisation.
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.”
Dr Cyrus Karkaria, President Biotechnology, Lupin, said, “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.”
Lupin’s biosimilar ranibizumab will be commercialised by Sandoz across the European Union, excluding Germany. In France, the product will be commercialised by Sandoz and Biogaran.