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 Dec 14, 2020
Woo SJ, Veith M, Hamouz J, et al. - In this randomized, double-masked, parallel-group phase 3 equivalence study, researchers sought to demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11, a proposed ranibizumab biosimilar product, compared with the reference ranibizumab. The sample consisted of 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. According to findings, SB11 showed equivalence in efficacy for both primary endpoints: adjusted treatment differences between groups were within predefined equivalence margins for mean changes from baseline in both BCVA at week 8 and CST at week 4. The safety and immunogenicity profiles between SB11 and ranibizumab were identical. Such findings suggest that SB11 is comparable to its reference product, ranibizumab.
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