Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration: A randomized clinical trial
JAMA Ophthalmology Jan 23, 2021
Woo SJ, Veith M, Hamouz J, et al. - Since neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older, researchers conducted this randomized, double-masked, parallel-group phase 3 equivalence study to illustrate the equivalence of efficacy, similar safety, and similar immunogenicity of SB11, a proposed ranibizumab biosimilar product, compared with the reference ranibizumab. This investigation was carried out in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. For patients with neovascular age-related macular degeneration, these results of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11.
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