Lupin has received a positive opinion recommending marketing authorization 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 humanized 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 neovascularization (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 centralized marketing authorization for EU member countries. As per the recently announced agreement, Lupin’s biosimilar ranibizumab will be commercialized by Sandoz Group AG across the European Union (excluding Germany). In France, the product will be commercialized by two companies, Sandoz AG and Biogaran.
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.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1837.15 |
| Dr. Reddys Lab | 1271.55 |
| Cipla | 1353.85 |
| Zydus Lifesciences | 1070.90 |
| Lupin | 2351.90 |
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