New Launch17 Dec 2025, 12:01 pm
Lupin Receives Positive CHMP Opinion for Biosimilar Ranibizumab
AI Summary
Global pharma major Lupin Limited announced 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, Ranluspec™, for both vial and pre-filled syringe presentations. 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. Lupin’s biosimilar ranibizumab will be commercialized by Sandoz Group AG across the European Union (excluding Germany).
Key Highlights
- Lupin's biosimilar ranibizumab, Ranluspec™, receives positive CHMP opinion for marketing authorization in the EU.
- The positive opinion is based on a demonstration of similarity to the reference product, including a 600-patient global phase III clinical trial in patients with Neovascular AMD.
- Lupin's biosimilar ranibizumab will be commercialized by Sandoz Group AG across the European Union (excluding Germany).
- Ranibizumab is used 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).
- Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets.