Clinical Trials
0
0 active
Approvals
8
Total approvals
Agencies
2
Regulatory bodies
Founded
1996
No trial phase data available
No trial data available
No trial data available
- Lupin expects biosimilar turnover of close to $500 million over the next five years, anchored by its recently approved pegfilgrastim biosimilar and upcoming ranibizumab launches. - The company has invested about ₹500 crore in biosimilar manufacturing capacity and plans to raise total investment to roughly ₹700 crore. - Lupin has begun raising external funding for Kaveri Therapeutics, its oncology-focused spin-off housing two specialised oncology programmes, while intending to remain majority shareholder. - Biosimilars of nivolumab, dinutuzumab and pertuzumab are planned for India, alongside existing etanercept biosimilar sales in Europe and Japan through partnerships.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Lupin's biosimilar ranibizumab, Ranluspec, in both vial and pre-filled syringe presentations. - The biosimilar targets multiple serious eye conditions including neovascular age-related macular degeneration, diabetic macular edema, and proliferative diabetic retinopathy by inhibiting vascular endothelial growth factor A (VEGF-A). - 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. - Under a commercial agreement, Sandoz Group AG will market the biosimilar across the European Union (excluding Germany), with joint commercialization by Sandoz AG and Biogaran in France.
• Celltrion has received European regulatory approval to market its rituximab biosimilar under four different brand names - Truxima, Tuxella, Ritemvia, and Blitzima - in a unique market strategy. • The company's approach aims to maximize market share through potential partnerships with multiple distributors, building on their successful dual-brand strategy with their infliximab biosimilar. • Strategic differences in marketing authorizations include specific indications, with Ritemvia approved for chronic lymphocytic leukemia while Blitzima and Tuxella exclude this indication.
