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Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference
Yujie Liu1, Jianhua Xie1, Zhuxiang Li1
1Bio-Thera Solutions, Ltd, Guangzhou, China.
Summary
BAT1806/BIIB800 (Tofidence™/tocilizumab-bavi), a biosimilar of tocilizumab, shows no functional impact from minor quality attribute differences compared to reference tocilizumab (TCZ). This supports its similarity to TCZ.
Area of Science:
- Biopharmaceutical characterization
- Biosimilarity assessment
- Structure-activity relationships
Background:
- BAT1806/BIIB800 (Tofidence™/tocilizumab-bavi) is a biosimilar to tocilizumab (TCZ).
- Initial assessments showed high analytical and functional similarity.
- Minor attribute differences necessitated further investigation.
Purpose of the Study:
- To assess the potential impact of minor quality attribute differences between BAT1806/BIIB800 and TCZ.
- To characterize structure-activity relationships to confirm biosimilarity.
Main Methods:
- Conducted structure-activity relationship (SAR) studies.
- Investigated glycation, glycosylation, charge variants, hydrophobicity, oxidation, and deamidation.
- Utilized various investigative techniques on multiple lots.
Main Results:
- Higher average glycated protein content in BAT1806/BIIB800 did not affect biological activity.
- Minor differences in other attributes had no impact on interleukin-6 receptor binding or effector functions.
- Forced degradation studies showed comparable oxidation and deamidation trends.
Conclusions:
- No relevant differences in quality attributes impacting function were found between BAT1806/BIIB800 and TCZ.
- Observed differences between the biosimilar and reference product have no functional consequence.
- Results support the conclusion that BAT1806/BIIB800 is highly similar to TCZ.
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