Samsung Bioepis’s SB12, a Proposed Biosimilar to Soliris (eculizumab) Meet its 1EPs in P-I Study for Paroxysmal Nocturnal Haemoglobinuria
- The company reported the results from the P-I study to evaluate SB12 (300mg) vs eculizumab via IV infusion in a ratio (1:1:1) in 240 patients with PNH
- The study met all 1EPs that showed PK equivalence and comparable PD profiles b/w SB12 and eculizumab. The 2EPs included AUClast and Cmax while safety profiles including immunogenicity were also comparable b/w SB12, EU-sourced eculizumab, and US-sourced eculizumab treatment groups & no death or discontinuation due to TEAEs were observed
- Soliris is a humanized mAb that binds to the human C5 complement protein & is currently used for the treatment of PNH, aHUS, gMG, and NMOSD
Ref: Globe Newswire | Image: Samsung Bioepis
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