title: A randomized, double-blind, single-dose, two-arm, parallel study comparing pharmacokinetics, immunogenicity and tolerability of branded adalimumab and its biosimilar LBAL in healthy male volunteers.
abstract: OBJECTIVE
  This study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira®, in healthy volunteers.
  
  
  METHODS
  A randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs). Tolerability was also evaluated.
  
  
  RESULTS
  The PK characteristics of the test and reference drugs were comparable. The GMR (90% CIs) for Cmaxand AUCinfof LBAL to Humira were 1.01 (0.92-1.11) and 0.96 (0.83-1.10), respectively, which were within the conventional bioequivalence criteria of 0.80-1.25. No significant differences occurred in the frequency of subjects with anti-adalimumab antibody-positive responses between both drugs. Tolerability profiles including adverse events were also comparable.
  
  
  CONCLUSIONS
  The PK characteristics of the biosimilar LBAL and the originator Humira were similar. LBAL and Humira did not show significant differences in immunogenicity and both were well tolerated after a single SC injection.
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics , Seoul National University College of Medicine and Hospital , Seoul , Republic of Korea.
authors.forename: Kyoung Ryun
authors.initials: KR
authors.lastname: Park
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics , Seoul National University College of Medicine and Hospital , Seoul , Republic of Korea.
authors.forename: Hyewon
authors.initials: H
authors.lastname: Chung
authors.affiliation: b Biopharmaceutical Analysis , Life Science Research Institute, LG Chem R&D Campus , Daejeon , Republic of Korea.
authors.forename: Sung Mo
authors.initials: SM
authors.lastname: Yang
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics , Seoul National University College of Medicine and Hospital , Seoul , Republic of Korea.
authors.forename: SeungHwan
authors.initials: S
authors.lastname: Lee
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics , Seoul National University College of Medicine and Hospital , Seoul , Republic of Korea.
authors.forename: Seo Hyun
authors.initials: SH
authors.lastname: Yoon
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics , Seoul National University College of Medicine and Hospital , Seoul , Republic of Korea.
authors.forename: Joo-Youn
authors.initials: JY
authors.lastname: Cho
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics , Seoul National University College of Medicine and Hospital , Seoul , Republic of Korea.
authors.forename: In-Jin
authors.initials: IJ
authors.lastname: Jang
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics , Seoul National University College of Medicine and Hospital , Seoul , Republic of Korea.
authors.forename: Kyung-Sang
authors.initials: KS
authors.lastname: Yu
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D000328:Adult; D000917:Antibody Formation / Q000276:immunology; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D019540:Area Under Curve; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004311:Double-Blind Method; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; D000068879:Adalimumab
keywords: Adalimumab; Humira; anti-TNF; bioequivalence; pharmacokinetics