Samsung Bioepis Presents P-III Study Results of SB12, a Proposed Biosimilar to Soliris for Paroxysmal Nocturnal Hemoglobinuria at EHA 2022
- The P-III study evaluates SB12 vs eculizumab in 50 patients with PNH. At 26wk., the treatment was changed to reference eculizumab (TS1) or SB12 (TS2), and the new regimen was continued until 50wk.
- The purpose of the study was to determine clinical efficacy by evaluating the level of LDH, safety, PK, PD, and immunogenicity of SB12 and reference eculizumab
- The results showed clinical equivalence in efficacy, safety, PK, PD, and immunogenicity b/w SB12 and reference eculizumab in patients with PNH. The study's results showed a 95% CI of mean difference in LDH level @26wk.; 90% CI ratio of time-adjusted AUEC of LDH b/w SB12 & eculizumab lay within the pre-defined equivalence margin
Ref: Globenewswire | Image: Samsung Bioepis
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