Biosimilar anti-vascular endothelial growth factor agents: Clinical outcomes, safety, and cost-effectiveness in India

Retinal vascular diseases, including neovascular age-related macular degeneration, diabetic macular edema, retinal vein occlusion, myopic choroidal neovascularization, and retinopathy of prematurity, are a major cause of visual morbidity in India. Although anti-vascular endothelial growth factor (anti-VEGF) therapy has transformed the management of these conditions, long-term outcomes in real-world Indian practice are frequently limited by affordability-related undertreatment. The introduction of biosimilar anti-VEGF agents, particularly ranibizumab biosimilars, has therefore assumed critical importance in improving access to sustained retinal care. This narrative review synthesizes the available Indian evidence on the clinical efficacy, safety, immunogenicity, and cost-effectiveness of biosimilar anti-VEGF agents. A comprehensive literature search was conducted in PubMed, MEDLINE, EMBASE, and Scopus from inception through September 2025 using predefined keywords related to biosimilar ranibizumab, retinal vascular diseases, safety, immunogenicity, real-world evidence, and cost-effectiveness. Additional studies were identified through manual screening of reference lists. Peer-reviewed English-language randomized trials, phase 3 studies, post-marketing surveillance reports, and large real-world cohorts from India were included. Across major retinal indications, phase 3 trials consistently demonstrated equivalence or noninferiority of biosimilars to the reference molecule in visual and anatomical outcomes, with comparable safety and low immunogenicity. Large real-world datasets further corroborate these findings and provide reassurance regarding ophthalmic use of biosimilar anti-VEGF. Importantly, reduced treatment costs have translated into improved treatment initiation and adherence. Overall, current evidence supports biosimilar ranibizumab as a safe, effective, and cost-effective alternative for retinal diseases in resource-limited settings.