Lupin Limited has achieved a significant regulatory milestone after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorisation for its biosimilar ranibizumab, branded as Ranluspec™. The recommendation covers both vial and pre-filled syringe presentations, marking an important step toward Lupin’s expansion in the European biosimilars market.
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment designed to bind to and inhibit vascular endothelial growth factor A (VEGF-A), a key driver of abnormal blood vessel growth in retinal disorders. The biosimilar is intended for use across multiple ophthalmic indications, 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 CHMP’s positive opinion is based on a comprehensive demonstration of biosimilarity to the reference product. This includes detailed analytical similarity assessments as well as data from a large global Phase III clinical trial involving around 600 patients with neovascular AMD. The trial was conducted across multiple regions, including the United States, European Union, Russia, and India, reinforcing the robustness of the clinical evidence.
Following the CHMP recommendation, the opinion will now be reviewed by the European Commission. Upon approval, the European Commission is expected to grant a centralized marketing authorization, allowing Ranluspec™ to be marketed across European Union member states.
As per a previously announced commercial agreement, Lupin’s biosimilar ranibizumab will be marketed across the European Union by Sandoz Group AG, excluding Germany. In France, the product will be commercialized jointly by Sandoz AG and Biogaran, ensuring broader market access in one of Europe’s key pharmaceutical markets.
