Samsung Bioepis Reports P-I Study Results of SB12, a Proposed Biosimilar to Soliris (eculizumab) for Paroxysmal Nocturnal Hemoglobinuria
Shots:
- The P-I study evaluates the PK, PD, safety, and immunogenicity of SB12 (300mg, IV) vs Soliris in 240 healthy adult patients with PNH
- The results showed PK bioequivalence and similar PD, safety, and immunogenicity profiles of SB12 vs reference eculizumab, 90% CIs of the geometric least squares means ratios of the PK EPs were fully contained within the pre-defined bioequivalence margin of 80-125%
- In the SB12/EU & US reference eculizumab, 68.8% experienced TEAEs (70.0%/65.0%/71.3%); ADAs were detected in (2.5%/1.3%/0%) with no neutralizing Abs in ADA+ patients. Eculizumab can reduce the risk of hemolysis and thrombosis in PNH, atypical HUS, generalized MG & NMO spectrum disorder
Ref: AJMC | Image: Samsung Bioepis
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