Lupin Receives European Commission Approval for Biosimilar Ranibizumab
Lupin Limited announced European Commission approval for its biosimilar ranibizumab, branded as Ranluspec™, available in vials and pre-filled syringes formats. The biosimilar treats various eye conditions including age-related macular degeneration and diabetic complications. Sandoz will handle commercialization across the European Union excluding Germany, while France will see dual commercialization through both Sandoz and Biogaran.

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Lupin has achieved a major regulatory milestone with the European Commission granting approval for its biosimilar ranibizumab, Ranluspec™. This approval represents a significant advancement in the company's biologics development program and expands its presence in the European pharmaceutical market.
Product Details and Therapeutic Applications
Ranluspec™ is available in both vials and pre-filled syringes formats, following a positive opinion from the Committee for Medicinal Products for Human Use. The biosimilar is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A.
| Parameter: | Details |
|---|---|
| Product Name: | Ranluspec™ |
| Active Ingredient: | Biosimilar Ranibizumab |
| Formats: | Vials and Pre-filled Syringes |
| Regulatory Authority: | European Commission |
| Primary Partner: | Sandoz |
The therapeutic indications for Ranluspec™ encompass treatment of patients with neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization.
Partnership and Market Distribution
Lupin's biosimilar ranibizumab will be commercialized by Sandoz across the European Union, excluding Germany. The distribution strategy includes a specialized approach for France, where the product will be commercialized by both Sandoz and Biogaran, ensuring comprehensive market coverage.
Leadership Perspectives
Thierry Volle, President EMEA and Emerging Markets at Lupin, emphasized the achievement as validation of the company's scientific capabilities and manufacturing excellence. The approval reinforces Lupin's commitment to expanding access to innovative, high-quality, and affordable biologic therapies for underserved patients worldwide.
Dr. Cyrus Karkaria, President Biotechnology at Lupin, highlighted that the European Commission approval represents a milestone validating the company's unwavering commitment and scientific standards to making advanced biologic therapies more accessible to patients.
Strategic Impact on Biologics Market
This regulatory approval strengthens Lupin's position in the competitive biosimilars market while supporting healthcare systems with more affordable alternatives to reference biologics. The partnership with Sandoz leverages established distribution networks and market expertise to ensure effective product commercialization throughout the approved territories.
Historical Stock Returns for Lupin
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +0.99% | +1.91% | +3.37% | +15.52% | +13.35% | +125.15% |


































