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 records 10 February 2026 as the marketing-authorisation date. Approved in vial and pre-filled syringe presentations, Ranluspec was launched by commercial partner Sandoz across Europe on 12 November 2026.

Indications and European launch

The partnership was announced in August 2025. The launch covers European markets except Germany, where Sandoz markets Epruvy, another ranibizumab product, under a separate agreement. Ranluspec is developed, manufactured and registered by Lupin.

Its approved uses include neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, proliferative diabetic retinopathy and choroidal neovascularisation. Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A (VEGF-A). Ranluspec has equivalent efficacy and comparable safety to the reference medicine, Lucentis.

Important Facts for Exams

• Antibody lineage: Ranibizumab is a Fab antibody fragment created from the same parent mouse antibody as bevacizumab.
• VEGF-A inhibition: Ranibizumab inhibits angiogenesis by blocking vascular endothelial growth factor A, a mechanism it shares with bevacizumab.
• Intravitreal delivery: Ranibizumab medicines are administered intravitreally, by injection into the vitreous humour of the eye.