India-based pharma company Lupin has received approval from the European Commission (EC) for its biosimilar ranibizumab, marketed as Ranluspec, in both vial and pre-filled syringe presentations. The approval follows a recent positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Ranluspec is indicated for the treatment of multiple ophthalmic conditions, including wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and choroidal neovascularization (CNV).

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