Lupin has received approval from the European Commission for its biosimilar ranibizumab, marketed as Ranluspec (available in vials and pre-filled syringes). The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A). It is indicated for the treatment of several serious retinal conditions, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy and choroidal neovascularisation.

Thierry Volle, President – EMEA and Emerging Markets, Lupin, said the approval highlights the company’s strong scientific and manufacturing capabilities and reinforces its commitment to expanding global access to high-quality, affordable biologic therapies.

Dr Cyrus Karkaria, President – Biotechnology, Lupin, described the approval as a significant milestone validating the company’s scientific standards and dedication to improving accessibility to advanced biologic treatments.

Lupin’s biosimilar ranibizumab will be commercialised by Sandoz across the European Union, excluding Germany. In France, the product will be marketed by both Sandoz and Biogaran.