Samsung Bioepis Presents Two P-III Studies Results of SB11 (biosimilar, ranibizumab) for Neovascular Age-Related Macular Degeneration at AAO 2022
- The 2 studies determine the ranibizumab biosimilar impact on patient outcomes. The post hoc analysis of a P-III trial determines the baseline factors to predict visual acuity & anatomical outcomes with the biosimilar vs Lucentis & efficacy outcomes after 1yr. of SB11 vs Stelara
- In a linear regression model, lower gain in BCVA of 1.9 letters and a greater CST reduction of 12.6mcm @52wk., similar therapy effects were observed b/w SB11 & reference product in the subgroup analysis
- The correlation analysis from the P-III trial of SB11 vs Lucentis (ITV, 0.5mg, q4w) showed a low immunogenicity profile & similar to the reference product, the cumulative incidence of an ADA+ response was low with the immunogenicity result (4.2% vs 5.5%) @52wk.
Ref: Centerforbiosimilar | Image: Samsung Bioepis
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