Xbrane announced that the US Food and Drug Administration (FDA) approved ranibizumab-blrz (Lucamzi), a biosimilar to ranibizumab (Lucentis; Genentech) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and other serious eye conditions. According to a company press release, Xbrane and its partners are finalizing preparations for a commercial launch in the United States in 2027.

The approval was supported by a comprehensive comparative analytical assessment of the drug's structural and functional characteristics, as well as a phase 3 clinical study involving 582 patients with wet AMD. According to Xbrane, the study demonstrated equivalent efficacy and comparable safety to the reference product.

Ranibizumab is an anti-VEGF therapy used to treat retinal vascular disorders. Xbrane said increased biosimilar competition could provide cost-effective treatment options, potentially reducing health care costs and improving patient access.