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Samsung Bioepis’ supplemental of Byooviv has being approved by FDA for an interchangeable intravitreal injection in neovascular AMD, RVO and myopic CNV

Samsung Bioepis announced that the FDA (Food and Drug Administration) has approved the supplemental biologics license application (BLA) for Byooviz (ranibizumab-nuna) as a biosimilar product interchangeable with Lucentis (ranibizumab).  This latest approval designates Byooviz as interchangeable across all of these approved indications.  The FDA had required that the information presented in the application is sufficient demonstrating that “the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and its reference product is not greater than the risk of using the reference product without such alternation or switch”.


Previously, the US FDA approved authorisation for Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) “for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD)”. The biosimilar is also approved to treat macular edema following retinal vein occlusion and myopic choroidal neovascularization.  The regulatory agency had shown how the mechanism of how biological products are generated and how equivalent they are to the reference product.  This communication was to clearly show the public that the new biosimilar has no clinically meaningful differences in terms of safety, purity, potency and effectiveness, compared to the original reference product.  Consequently, patients should have confidence that the approved biosimilar is safe and effective.


The approval of Byooviz was under-pinned by analytical, non-clinical data, and clinical data from a randomized, double-masked, parallel group, multi-center Phase III study of the product (termed “SB11”). The efficacy, safety, pharmacokinetics, and immunogenicity of the biosimilar was compared to “reference ranibizumab” patients with 705 wet AMD subjects who were randomized (1:1) to receive the biosimilar or reference ranibizumab in monthly injections (0.5mg).  634 patients continued to receive treatment up to week 48 and the least squares (LS) mean change in BCVA from baseline at week 52 was 9.79 letters for the biosimilar, compared with 10.41 letters for ranibizumab (difference: -0.62, [90% CI: -2.092, 0.857]). The LS mean change in central subfield thickness (CST) was −139.55 μm for the biosimilar compared to −124.46 μm for ranibizumab (difference: -15.09, [95% CI, -25.617, -4.563]). Pharmacokinetics and safety, including incidence of treatment-emergent adverse events and the immunogenicity profile of the biosimilar was comparable at all timepoints up to week 52.