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
    4 Citations

    Figures, Tables, and Topics from this paper

    Explore Further: Topics Discussed in This Paper

    References

    SHOWING 1-10 OF 39 REFERENCES
    Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar
    • 62
    Expert perspectives on biosimilar monoclonal antibodies in breast cancer
    • 49
    • PDF
    Fc glycans of therapeutic antibodies as critical quality attributes
    • 190
    • PDF
    Mechanism of action of anti-HER2 monoclonal antibodies.
    • J. Baselga, J. Albanell
    • Medicine
    • Annals of oncology : official journal of the European Society for Medical Oncology
    • 2001
    • 219
    The Global Need for a Trastuzumab Biosimilar for Patients With HER2‐Positive Breast Cancer
    • 20