Lupin Limited has received approval from the European Commission for its biosimilar ranibizumab, branded as Ranluspec, in both vial and pre-filled syringe presentations.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), clearing the way for marketing authorisation across the European Union.
Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), a key driver of abnormal blood vessel growth in retinal diseases. The therapy is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, proliferative diabetic retinopathy and choroidal neovascularisation.
The approval marks a significant step in Lupin’s biologics portfolio expansion in regulated markets and strengthens its presence in ophthalmology. The company stated that the authorisation reinforces its focus on advancing high-quality, affordable biologic therapies.
Lupin’s biosimilar ranibizumab will be commercialised by Sandoz across the European Union, excluding Germany. In France, the product will be marketed by Sandoz and Biogaran.
The development positions Lupin to compete in the growing European ophthalmology biosimilars segment, where cost-effective alternatives are expected to improve patient access to anti-VEGF therapies.
