Lupin gets positive CHMP opinion for Biosimilar Ranibizumab; shares jump 1%

Shares of Lupin closed in green following the positive development for marketing authorisation of a biosimilar ranibizumab. The shares closed 1.1% higher at ₹2,114 apiece on the NSE.

Lupin has received a positive opinion recommending marketing authorisation for its biosimilar ranibizumab, Ranluspec, for both vial and pre-filled syringe presentations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). 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 oedema following retinal vein occlusion (RVO), diabetic macular oedema (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. 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.

Additionally, the company also announced receiving an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its injectable facility in Nagpur, India, with a satisfactory Voluntary Action Indicated (VAI) classification. The EIR was issued following an inspection of the facility from September 8 to September 16, 2025.

Lupin is an innovation-led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.