European Commission Approves Lupin’s Ranibizumab Biosimilar
The European Commission granted marketing authorisation to Lupin Limited’s ranibizumab biosimilar, Ranluspec, on 23 February 2026. The European Medicines Agency recorded 10 February 2026 as the marketing-authorisation date.
Launch Details
Ranluspec was launched by commercial partner Sandoz across Europe on 12 November 2026. This launch covers European markets excluding Germany, where Sandoz markets Epruvy, another ranibizumab product, under a separate agreement.
Product Information
Ranluspec is developed, manufactured, and registered by Lupin. It is designed to be equivalent in efficacy and safety to the reference medicine, Lucentis.
Approved Uses
The biosimilar is approved for use in treating neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, proliferative diabetic retinopathy, and choroidal neovascularisation.
About Ranibizumab
Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A (VEGF-A).
Partnership Background
The partnership between Lupin and Sandoz was announced in August 2025.
Next Steps
Currently, no further announcements have been made regarding the rollout of Ranluspec in specific European countries beyond the initial launch date.
Source: GK Today.
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