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FDA approval announces the first biosimilar in the USA for ranibizumab (Lucentis) intravitreal injection in neovascular AMD, RVO and myopic CNV

The US FDA (Food and Drug Administration) has 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 included a brief summary in their press statement to show 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 FDA 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 (0.5 mg).  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.  The two companies supporting the biosimilar (Samsung Bioepis & Biogen) will not be marketed in the US until June 2022.  Byooviz was approved in the European Union on August 18, and in the UK on August 31, 2021.


Commenting on the announcement, Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, stated that “approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products.  Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs”.