Population pharmacokinetic, pharmacodynamic and efficacy modeling of SB12 (proposed eculizumab biosimilar) and reference eculizumab.
Hyuna LeeJihye ParkHyerin JangSo Jin LeeJungryul Kim
Published in: European journal of clinical pharmacology (2024)
The population modeling showed PK, PD and efficacy similarities between SB12 and ECU in pooled population of healthy subjects and PNH patients, supporting the totality of evidence on biosimilarity for SB12.