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Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab.

Yujie LiuJianhua XieZhuxiang LiXiong MeiDi CaoShengfeng LiLinda EngleSuli LiuHans C EbbersCuihua Liu
Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2024)
BAT1806/BIIB800 and TCZ were highly similar for all critical quality attributes. Where differences were observed in less critical quality attributes, additional analytical assessments and clinical study results determined these to be not clinically meaningful.
Keyphrases
  • rheumatoid arthritis
  • quality improvement
  • clinical trial
  • mass spectrometry