Samsung Bioepis Reports P-III Equivalence Study Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration
Shots:
- 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
Related News:- Samsung Bioepis Reports P-III Study Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
