Lupin receives European Commission approval for Biosimilar Ranibizumab

Lupin has received the approval from European Commission for its biosimilar ranibizumab, RanluspecTM (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.

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.

 

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