FDA Approves Xbrane’s LUCAMZI™, a Biosimilar to LUCENTIS®
On October 29, 2026, Xbrane Biopharma announced that the FDA approved LUCAMZI (ranibizumab-blrz), a biosimilar to LUCENTIS® (ranibizumab). Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy used to treat retinal vascular disorders, including neovascular (wet) age-related macular degeneration.
According to Xbrane, the approval was supported by comparative structural and functional analytical assessments and a Phase 3 clinical study involving 582 patients with wet age-related macular degeneration. The company reported that the study demonstrated equivalent efficacy and comparable safety to the reference product. Xbrane stated that it is finalizing preparations with its partners for a U.S. commercial launch in 2027.
Xbrane’s LUCAMZi is the fifth ranibizumab biosimilar approved by the FDA, behind Samsung Bioepis’ BYOOVIZ (ranibizumab-nuna) (approved in September 2021), Coherus’ CIMERLI (ranibizumab-eqrn) (approved in August 2022), Formycon’s NUFYMCO (ranibizumab-leyk) (approved in December 2025), and Lupin’s RANLUSPEC (ranibizumab-hkdz) (approved in June 2026).
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