Efficacy and safety of ranibizumab biosimilar for retinal diseases: A systematic review and meta-analysis

Intravitreal antivascular endothelial growth factors like ranibizumab have been shown to be efficacious and safe for treating retinal diseases, but high cost limits their use. Biosimilar drugs provide a more affordable alternative. Razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), a ranibizumab biosimilar, was approved in India in 2015. Despite promising results, there is a lack of unbiased, independent systematic reviews and meta-analyses on its safety and efficacy.Systematic searches were conducted on Ovid MEDLINE, PUBMED, Web of Science, EMBASE, SCOPUS, and Cochrane. Eighteen studies with a total of 3740 eyes, and one safety trial with 9406 injections were included in this systematic review and meta-analysis. Razumab injections led to a significant improvement in best corrected visual acuity, a decrease in central macular thickness in patients with neovascular age-related macular degeneration, macular edema due to diabetes and retinal vein occlusion, and a significant regression in retinopathy of prematurity, but there was heterogeneity between the studies and potential publication biases. The overall proportion of adverse events was around 17.1%, with the majority being nonserious. This study showed that Razumab led to improvement in visual outcomes and a decrease in retinal thickness with an acceptable safety profile, but there was variability and potential publication biases in the studies included. Long-term and independent trials are needed for greater evidence.