A Randomized Pharmacokinetic Study in Healthy Male Subjects Comparing a High-concentration, Citrate-free SB5 Formulation (40 mg/0.4 ml) and Prior SB5 (Adalimumab Biosimilar)

• Published in: Rheumatology and therapy. Vol. 9; no. 4; pp. 1157 - 1169
• Main Authors: Ahn, So-shin, Lee, Minkyung, Baek, Yumin, Lee, Sukho
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.08.2022; Springer Nature B.V
• Subjects: Bioequivalence; Biological products; Family Medicine; General Practice; Internal Medicine; Medicine; Medicine & Public Health; Monoclonal antibodies; NCT; NCT04514796; Original Research; Orthopedics; Quality of Life Research; Rheumatology; Tumor necrosis factor-TNF; Bioequivalence; Pharmacokinetics; TNF inhibitor; Biosimilar; SB5

Introduction SB5 is an approved biosimilar of adalimumab, a monoclonal anti-tumor necrosis factor (anti-TNF) antibody. This study compared pharmacokinetics (PK), safety, tolerability, and immunogenicity between a new high-concentration, low-volume, and citrate-free formulation (40 mg/0.4 ml, SB5-HC)...