Lupin's biosimilar ranibizumab gets positive EU opinion

Global pharmaceutical company Lupin Limited (Lupin) announced on December 17, 2025, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion. This opinion recommends marketing authorization for Lupin's biosimilar ranibizumab, Ranluspec™, available in both vial and pre-filled syringe presentations.

Ranibizumab is an IgG1 monoclonal antibody fragment used to treat various ophthalmic 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 analytical similarity assessment and a 600-patient global phase III clinical trial conducted in the US, EU, Russia, and India.

The CHMP's positive opinion will now be reviewed by the European Commission (EC) for a centralized marketing authorization across EU member countries. Sandoz Group AG will commercialize Lupin's biosimilar ranibizumab throughout the European Union (excluding Germany), with Sandoz AG and Biogaran handling commercialization in France.