[Biosimilars of ranibizumab in retinal diseases: new possibilities in ophthalmology].

Abstract

The development of biological therapeutic agents has provided new opportunities for treating neovascular age-related macular degeneration (nAMD) using humanized monoclonal antibodies (mAbs) targeting vascular endothelial growth factor A (VEGF-A). The emergence of biosimilars of anti-VEGF agents can significantly improve treatment accessibility and its effectiveness by increasing patient adherence. The development of biosimilars involves comparative studies with the original drug to establish equivalence in physicochemical and biological properties, efficacy, and safety. Biosimilar development programs include extensive analytical and preclinical studies to compare structural and functional components with the original bioproduct, and clinical trials are conducted to prove bioequivalence and therapeutic equivalence. The process of development and registration of the biosimilars is strictly regulated and has no significant differences in Russia, the EU and the US. Currently, more than 10 biosimilars of ranibizumab have been approved worldwide, in Russia it is the drug Laxolan (AO GENERIUM). The introduction of a domestic biosimilar of ranibizumab into clinical practice allows reduction of the costs of retinal disease treatment while maintaining the efficacy and safety of antiangiogenic therapy.