Lupin Receives Positive CHMP Opinion for Biosimilar Ranibizumab
Filing Summary
Lupin Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending marketing authorization for its biosimilar ranibizumab, RanluspecTM. This recommendation covers both vial and pre-filled syringe presentations. The positive opinion is based on a demonstration of similarity to the reference product, including a global phase III clinical trial. The European Commission will now consider this opinion for centralized marketing authorization across EU member countries. Sandoz Group AG will commercialize the product in the EU, excluding Germany.
Lupin Limited announced on December 17, 2025, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for its biosimilar ranibizumab, RanluspecTM. This recommendation includes both vial and pre-filled syringe presentations.
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). It is indicated for the treatment of patients with 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 based on a demonstration of similarity to the reference product, which included an analytical similarity assessment and a 600-patient global phase III clinical trial conducted in the US, EU, Russia, and India. The European Commission will now consider this opinion for granting a centralized marketing authorization for EU member countries.
According to the agreement, Sandoz Group AG will commercialize Lupin’s biosimilar ranibizumab across the European Union, excluding Germany. In France, the product will be commercialized by both Sandoz AG and Biogaran.
Lupin Limited is a global pharmaceutical leader with a focus on branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates in over 100 markets and has a strong presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.