Physicochemical and biological similarity assessment of LBAL, a biosimilar to adalimumab reference product (Humira®)

Joon Cheol Kwon, O. Hwan Kwon, Rae Ung Jeong, Nayoun Kim, Seonah Song, Ilsub Choi, Juneok Lee, Takahiko Horiuchi

研究成果: ジャーナルへの寄稿学術誌査読

4 被引用数 (Scopus)

抄録

LBAL was developed as an adalimumab (Humira®) biosimilar using Chinese hamster ovary cell lines. Comparable quality, safety, and efficacy between a biosimilar and its reference product should be ensured for regulatory approval. Here, we present the results of a comprehensive physicochemical and biological characterization between LBAL and Humira®. As physicochemical attributes, primary and higher-order structure, N-glycan profile, and disulfide linkage were investigated. Biological attributes were evaluated by target/receptor binding analysis and in vitro/ex vivo cell-based assays, which are linked to mechanisms of action. As a result, LBAL had the identical amino acid sequence, similar post-translational modifications and N-/C-terminal variants, and comparable primary, secondary, and tertiary structures and disulfide linkage profile. However, some differences in N-glycan profiles were observed. Biological activities, including tumor necrosis factor (TNF) binding, TNF-neutralization, apoptosis, Fc receptor binding, and complement-dependent cytotoxicity, were largely consistent. Despite a slightly lower antibody-dependent cellular cytotoxicity activity in LBAL, this difference was not significant under physiological conditions. As indicated, this extensive analytical characterization and functional comparison assessment showed that LBAL was similar to Humira®, with minor differences of no clinical relevance. Taken together, our comparative assessment of physicochemical and biological attributes demonstrated that LBAL is structurally and functionally very similar to Humira®, supporting the biosimilarity of clinical efficacy and safety.

本文言語英語
ページ(範囲)182-194
ページ数13
ジャーナルAnimal Cells and Systems
25
3
DOI
出版ステータス出版済み - 2021

!!!All Science Journal Classification (ASJC) codes

  • 動物科学および動物学
  • 生化学、遺伝学、分子生物学一般

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