BACKGROUND/AIMS: To 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. RESULTS: Baseline 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. CONCLUSIONS: Longer-term results of this study further support the biosimilarity established between SB11 and RBZ.

Department of Ophthalmology 3rd Faculty of Medicine Charles University Prague Czech Republic

Department of Ophthalmology Asan Medical Center Songpa gu Seoul South Korea

Department of Ophthalmology Bajcsy Zsilinszky Hospital and Clinic Budapest Hungary

Department of Ophthalmology Central Military Hospital Praha Czech Republic

Department of Ophthalmology Faculty of Medicine in Hradec Kralove Charles University Hradec Kralove Czech Republic

Department of Ophthalmology Faculty of Medicine Masaryk University Brno Czech Republic

Department of Ophthalmology Hungarian Defence Forces Medical Centre Budapest Hungary

Department of Ophthalmology Semmelweis University Budapest Hungary

Department of Ophthalmology Seoul National University Bundang Hospital Seongnam South Korea

Department of Ophthalmology Seoul National University College of Medicine Seoul South Korea

Department of Ophthalmology University Hospital Kralovske Vinohrady Prague Czech Republic

Department of Ophthalmology University of Debrecen Debrecen Hajdú Bihar Hungary

Diagnostic and Microsurgery Center of the Eye LENS Olsztyn Poland

Johns Hopkins Medicine Wilmer Eye Institute Baltimore Maryland USA

Retina Consultants of Southern Colorado PC Colorado Springs Colorado USA

Samsung Bioepis Co Ltd Incheon South Korea

University Hospital Brno Brno Czech Republic

University Hospital Hradec Kralove Hradec Kralove Královéhradecký Czech Republic

University Hospital Kralovske Vinohrady Praha Czech Republic

University of Ulsan College of Medicine Songpa gu Seoul South Korea

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