Lupin's Biosimilar Ranibizumab Ranluspec Receives Positive EMA Committee Opinion for Multiple Eye Conditions
核心洞察
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Lupin's biosimilar ranibizumab, Ranluspec (搜索), in both vial and pre-filled syringe presentations.
The biosimilar targets multiple serious eye conditions including neovascular age-related macular degeneration (搜索), diabetic macular edema (搜索), and proliferative diabetic retinopathy (搜索) by inhibiting vascular endothelial growth factor A (搜索) (VEGF-A (搜索)).
The positive opinion is supported by comprehensive analytical similarity assessments and a global Phase III clinical trial involving 600 patients with neovascular AMD conducted across the US, EU, Russia, and India.
Global pharmaceutical company Lupin Limited has achieved a significant regulatory milestone with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (搜索) (EMA) adopting a positive opinion recommending marketing authorization for its biosimilar ranibizumab, branded as Ranluspec (搜索). The recommendation covers both vial and pre-filled syringe presentations, marking an important step toward expanding access to affordable eye treatments across Europe.
Targeting Critical Eye Conditions
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (搜索) (VEGF-A (搜索)), a key driver of abnormal blood vessel growth in retinal disorders. The biosimilar is indicated for treating patients with neovascular (wet) age-related macular degeneration (AMD), macular edema (搜索) following retinal vein occlusion (搜索) (RVO), diabetic macular edema (搜索) (DME), proliferative diabetic retinopathy (搜索) (PDR), and choroidal neovascularization (搜索) (CNV).
Robust Clinical Evidence Supporting Approval
The CHMP's positive opinion is based on a comprehensive demonstration of similarity to the reference product, including detailed analytical similarity assessments and data from a substantial global Phase III clinical trial. The pivotal study involved approximately 600 patients with neovascular AMD and was conducted across multiple regions, including the United States, European Union, Russia, and India, reinforcing the robustness of the clinical evidence.
"We are very 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," said Thierry Volle, President EMEA and Emerging Markets at Lupin.
Commercial Strategy and Market Access
The CHMP positive opinion will now be considered by the European Commission (EC), which is expected to grant a centralized marketing authorization for EU member countries upon approval. Under a previously announced commercial agreement, Lupin's biosimilar ranibizumab will be marketed across the European Union by Sandoz Group AG, excluding Germany. In France, the product will be commercialized jointly by Sandoz AG and Biogaran, ensuring broader market access in one of Europe's key pharmaceutical markets.
Company Background
Lupin Limited is a Mumbai-headquartered global pharmaceutical company with products distributed in over 100 markets. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin maintains a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health, supported by 15 state-of-the-art manufacturing sites and 7 research centers globally.