Wet age-related macular degeneration (wAMD) is a leading cause of treatable vision loss in elderly patients. Wet AMD vision loss is characterized by the overexpression of vascular endothelial growth factor (VEGF), which triggers choroidal neovascularization and the leakage of blood/fluid into the macula. Anti-VEGF treatments have led to remarkable vision gains in many patients with wAMD.

Ranibizumab, a humanized monoclonal antibody fragment was the first FDA approved anti-VEGF agent to demonstrate improvement in visual acuity in those with wet AMD. Previously, patients were treated with lasers including PDT which led to stabilization of vision but not vision gains in the majority of patients. Intravitreal anti-VEGF is now, without question, the standard of care for wAMD in the USA and worldwide.

The first ranibizumab biosimilar was recently FDA-approved for wAMD based on an extensive review of evidence, which included structural/functional characterization and clinical/safety analyses. In the global, randomized, double-masked, parallel phase 3 equivalence study of 705 patients with AMD with subfoveal CNV, patients treated with ranibizumab-renu monthly were compared to monthly reference ranibizumab. The overall data suggest that the biosimilar and reference ranibizumab have comparable efficacy, safety, and immunogenicity, and the similarity of all primary and secondary efficacy endpoints was maintained at all timepoints up to week 52. According to the manufacturer, the price of the biosimilar is 40% lower than the reference biologic and has the potential to expand access to patients.

What are your thoughts on using the FDA-approved ranibizumab biosimilar in your practice?