Efficacy and safety of biosimilar fyb201 compared with ranibizumab in neovascular age-related macular degeneration

The authors are commenting on the study entitled: “Efficacy and safety of biosimilar FYB201 compared with ranibizumab in neovascular age-related macular degeneration” published by Holz et al in Ophthalmology 2021 (doi.org./10.1016/j.ophtha.2021.04.031. Published on May 2, 2021), which prospectively investigated the clinical equivalence of the biosimilar FYB201 (n = 238) and reference ranibizumab (n = 239) in 477 patients with treatment-naïve active subfoveal choroidal neovascularization caused by neovascular age-related macular degeneration. The best-corrected visual acuity improved in both groups with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) ETDRS letters at week 8 before the third monathly intravitreal injection. Biosimilarity of FYB201 to its original biolog ranibizumab was assessed via a 2-sided equivalence test with an equivalence margin in best-corrected visual acuity of 3 ETDRS letters. The authors concluded that FYB201 is similar to reference ranibizumab in terms of clinical efficacy and ocular and systemic safety in the treatment of patients with neovascular age-related macular degeneration. However, the validation, extrapolation, and generalizabilty of these findings can be made only by regression analyses including all the missing data referred to above by us in addition to the baseline characteristics already assessed in this study, serving to identify the potential prognosticators influencing the equivalence of biosimilar FYB201 and its bio-originator ranibizumab.