Lupin announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for its biosimilar ranibizumab, RanluspecTM, for both vial and pre-filled syringe presentations.

Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds to and inhibits Vascular Endothelial Growth Factor A (VEGF-A). Its indications encompass 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 Neovascularisation (CNV).

The positive CHMP opinion is based on a demonstration of similarity to the reference product, including an analytical similarity assessment and a 600-patient global phase III clinical trial in patients with Neovascular AMD, conducted in the US, EU, Russia and India.

Thierry Volle, President EMEA and Emerging Markets, Lupin, said, “We are pleased with the CHMP’s positive opinion for ranibizumab. This recognition underscores the quality of Lupin’s Biologics development and manufacturing as well as our relentless pursuit of affordable solutions that transform patient care.”

The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralised marketing authorisation for EU member countries. As per the recently announced agreement, Lupin’s biosimilar ranibizumab will be commercialised by Sandoz Group AG across the European Union (excluding Germany). In France, the product will be commercialised by two companies, Sandoz AG and Biogaran.