The first biosimilar of ranibizumab (Byooviz, Biogen, USA) has received approval from the United States- Food and Drug Administration (US-FDA) and European Medicines Agency (EMA) recently [1, 2]. And the International Retina Biosimilar Study Group (Inter BIOS Group) has conducted a survey (Bio-USER- unpublished data) which has revealed that many retinal physicians from Europe and the US have concerns regarding the safety of biosimilars. Safety is predominantly related to drug-induced intraocular inflammation (IOI) apart from nonocular safety parameters. Anti-vascular endothelial growth factors (Anti-VEGF) are biologics under the category of monoclonal antibodies. Biologics are exogenous proteins and thus, inherently have the potential to cause immunogenicity [3].

In this manuscript, we will try to compare the safety of ranibizumab biosimilar and innovator ranibizumab (Lucentis, Genentech, USA) by analyzing parameters used to assess safety in the landmark phase 3 trial that has led to the approval of these molecules [4,5,6]. All the biosimilar ranibizumab molecules are compared against the innovator (reference- Lucentis) molecule during the phase 3 trial. For better understanding, we will use the brand name in this manuscript.

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