Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes

• Published in: British journal of ophthalmology Vol. 107; no. 3; pp. 384 - 391
• Main Authors: Bressler, Neil M, Veith, Miroslav, Hamouz, Jan, Ernest, Jan, Zalewski, Dominik, Studnička, Jan, Vajas, Attila, Papp, András, Vogt, Gabor, Luu, James, Matuskova, Veronika, Yoon, Young Hee, Pregun, Tamás, Kim, Taehyung, Shin, Donghoon, Oh, Inkyung, Jeong, Hansol, Kim, Mercy Yeeun, Woo, Se Joon
• Format: Journal Article
• Language: English
• Published: BMA House, Tavistock Square, London, WC1H 9JR BMJ Publishing Group Ltd 01.03.2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Angiogenesis Inhibitors - therapeutic use; Biological products; Biosimilar Pharmaceuticals - therapeutic use; Clinical Science; Clinical trials; degeneration; FDA approval; Generic drugs; Humans; Intravitreal Injections; macula; Macular degeneration; Macular Degeneration - drug therapy; Middle Aged; Monoclonal antibodies; neovascularisation; Pharmacokinetics; R&D; Ranibizumab - therapeutic use; Research & development; retina; Sample size; Treatment Outcome; Vascular endothelial growth factor; Vascular Endothelial Growth Factor A; Visual Acuity; Wet Macular Degeneration - diagnosis; Wet Macular Degeneration - drug therapy; United States > US; South Korea; neovascularisation; retina; degeneration; macula
• ISSN: 0007-1161; 1468-2079
• DOI: 10.1136/bjophthalmol-2021-319637

Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).Methods Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.