Lupin Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for its biosimilar ranibizumab, RanluspecTM. This positive opinion applies to both vial and pre-filled syringe presentations. Ranibizumab is a crucial treatment for various eye conditions including neovascular (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). The positive CHMP opinion is supported by comprehensive data, including an analytical similarity assessment and a global Phase III clinical trial involving 600 patients with Neovascular AMD across the US, EU, Russia, and India. Thierry Volle, President EMEA and Emerging Markets at Lupin, expressed satisfaction with the CHMP's positive opinion, highlighting it as a testament to Lupin’s capabilities in Biologics development and manufacturing and its commitment to providing affordable solutions. The recommendation will now be reviewed by the European Commission (EC) for a centralized marketing authorization across EU member countries. Following approval, Lupin's biosimilar ranibizumab will be commercialized by Sandoz Group AG in the European Union (excluding Germany), and in France, it will be marketed by both Sandoz AG and Biogaran.
