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

Objectives: 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 C_max and AUC_inf of 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.

Conclusion: 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.

KEYWORDS:

• Adalimumab
• anti-TNF
• bioequivalence
• Humira
• pharmacokinetics

Acknowledgments

This study was designed and conducted by the Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital. The authors would like to thank the subjects who participated in the study, and the staff of the Clinical Trials Center, Seoul National University Hospital who carried out the study. All co-authors were involved in writing the manuscript. Kyoung Ryun Park, Hyewon Chung, SeungHwan Lee, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, and Kyung-Sang Yu designated, conducted and coordinated the study. Kyoung Ryun Park and Hyewon Chung analyzed and interpreted data and participated in drafting the manuscript. Sung Mo Yang conducted for bioanalytical assays, generated the data, reviewed interpretation of data analysis and revising the manuscript. SeungHwan Lee, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, and Kyung-Sang Yu performed data review and revising the manuscript for critical content. All authors read and approved the final manuscript.

Declaration of interest

S. M. Yang is an employee of LG Chem. Ltd (former LG Life Sciences, Ltd). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was funded by LG Chem. Ltd., Republic of Korea. (former LG Life Sciences, Ltd.)