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 authorization for its biosimilar ranibizumab, Ranluspec™, for both vial and pre-filled syringe presentations. Ranibizumab is used in treating neovascular (wet) age-related macular degeneration (AMD), macular edema, diabetic retinopathy and other conditions.
Positive CHMP Opinion
Lupin Limited has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding its biosimilar ranibizumab, Ranluspec™. This recommendation supports marketing authorization for both vial and pre-filled syringe presentations.
Ranibizumab Indications
Ranibizumab addresses several ophthalmic conditions:
- Neovascular (wet) age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Diabetic macular edema (DME)
- Proliferative diabetic retinopathy (PDR)
- Choroidal neovascularization (CNV)
Clinical Similarity
The positive CHMP opinion is grounded in the demonstration of similarity to the reference product. This includes an analytical similarity assessment and results from a 600-patient global phase III clinical trial conducted in the US, EU, Russia, and India.
Commercialization Strategy
Lupin’s biosimilar ranibizumab will be commercialized by Sandoz Group AG across the European Union (excluding Germany), in accordance with a previously announced agreement. In France, commercialization will be handled by both Sandoz AG and Biogaran.
Executive Commentary
Thierry Volle, President EMEA and Emerging Markets, Lupin, stated that the positive opinion underscores the quality of Lupin’s Biologics development and manufacturing. He emphasized the company’s commitment to affordable solutions that transform patient care.
Source: BSE