Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

@article{Kim2017DriftsIA,
  title={Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar},
  author={Seokkyun Kim and Jinsu Song and S. Park and S. Ham and Kyungyeol Paek and Minjung Kang and Y. Chae and Heewon Seo and Hyung-chan Kim and Michael Flores},
  journal={mAbs},
  year={2017},
  volume={9},
  pages={704 - 714}
}
A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. [...] Key Method For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the…Expand
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References

SHOWING 1-10 OF 29 REFERENCES
Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing
  • 61
Orthogonal Assessment of Biotherapeutic Glycosylation: A Case Study Correlating N-Glycan Core Afucosylation of Herceptin with Mechanism of Action.
  • 14
A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects.
  • 27
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
  • 404
  • Highly Influential
  • PDF
Superior in vivo efficacy of afucosylated trastuzumab in the treatment of HER2-amplified breast cancer.
  • 199
  • PDF
Trastuzumab: Updated Mechanisms of Action and Resistance in Breast Cancer
  • 348
Production, characterization and pharmacokinetic properties of antibodies with N-linked Mannose-5 glycans
  • 123
...
1
2
3
...