A randomized, double‐blind, single‐dose, three‐arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris®) in healthy male subjects

• Published in: European journal of haematology Vol. 105; no. 1; pp. 66 - 74
• Main Authors: Chow, Vincent, Pan, Jean, Chien, David, Mytych, Daniel T., Hanes, Vladimir
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.07.2020; John Wiley and Sons Inc
• Subjects: ABP 959; biosimilar; Complement component C5; Double-blind studies; eculizumab; Immunogenicity; Monoclonal antibodies; Original; paroxysmal nocturnal hemoglobinuria; Pharmacodynamics; Pharmacokinetics; United States > US; paroxysmal nocturnal hemoglobinuria; eculizumab; ABP 959; biosimilar

Objectives ABP 959 is a proposed biosimilar to eculizumab, a monoclonal antibody targeting the human C5 complement protein. The objective of this randomized, double‐blind, three‐arm, study was to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity of ABP 959 relative to the eculizum...