Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira® in healthy subjects

• Published in: British journal of clinical pharmacology Vol. 82; no. 4; pp. 983 - 993
• Main Authors: Hyland, Elizabeth, Mant, Tim, Vlachos, Pantelis, Attkins, Neil, Ullmann, Martin, Roy, Sanjeev, Wagner, Volker
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.10.2016
• Subjects: adalimumab; Adalimumab - adverse effects; Adalimumab - blood; Adalimumab - immunology; Adalimumab - metabolism; Adolescent; Adult; Biological Availability; biosimilar; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - blood; Biosimilar Pharmaceuticals - pharmacokinetics; Clinical Trials; Double-Blind Method; Female; Healthy Volunteers; Humans; Male; Middle Aged; pharmacokinetics; safety; Therapeutic Equivalency; Young Adult; pharmacokinetics; safety; adalimumab; biosimilar

Aims The aim of the study was to compare the pharmacokinetics (PK), safety and tolerability of the proposed adalimumab biosimilar MSB11022 (Merck) with Humira® (AbbVie), sourced from both the US (US reference product [US‐RP]) and Europe (European reference medicinal product [EU‐RMP]). Methods In thi...