• DOI:10.1007/s40259-020-00407-0
Corpus ID: 211139057

Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology

@article{Xie2020DemonstratingAS,
  title={Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology},
  author={Liqi Xie and Erhui Zhang and Yanpeng Xu and W. Gao and L. Wang and M. H. Xie and Peilan Qin and L. Lu and Sipeng Li and Pengcheng Shen and Weidong Jiang and S. Liu},
  journal={Biodrugs},
  year={2020},
  volume={34},
  pages={363 - 379}
}

Liqi Xie, Erhui Zhang, +9 authors S. Liu

Published 2020

Chemistry, Medicine

Biodrugs

A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes. The aim was to assess the analytical similarity between the trastuzumab biosimilar HLX02 and Europe-sourced Herceptin® (EU-Herceptin®) and China-sourced Herceptin® (CN-Herceptin®) following a quality-by-design (QbD) quality study and tier-based quality attribute evaluation. A panel of highly sensitive and… CONTINUE READING

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