Samsung Bioepis Reports P-III Equivalence Study Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration
- The P-III equivalence study evaluating the efficacy, safety, immunogenicity & PK of ranibizumab biosimilar SB11 (0.5mg, IVI) vs reference ranibizumab in a ratio (1:1) in patients aged ≥50yrs. with nAMD
- The results support biosimilarity b/w the treatment, the incidence of ocular TEAEs (32.0% vs 29.7%) & serious ocular TEAEs (2.9% vs 2.3%) seemed comparable with no new safety concerns while PK & immunogenicity profiles were comparable with a 4.2% and 5.5% cumulative incidence of antidrug Abs up to 52wk., baseline and disease characteristics were also comparable
- No clinical differences were seen b/w SB11 and ranibizumab. Primary and secondary efficacy EPs remained similar at all time points up to 52wk.
Ref: Centerforbiosimilar | Image: Samsung Bioepis
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