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

BACKGROUND: 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. OBJECTIVES: The aim was to assess the analytical similarity between the trastuzumab biosimilar HLX02 an...

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Bibliographic Details
Published in:BioDrugs
Main Authors: Xie, Liqi, Zhang, Erhui, Xu, Yanpeng, Gao, Wenyuan, Wang, Linlin, Xie, Michael Hongwei, Qin, Peilan, Lu, Lihong, Li, Sipeng, Shen, Pengcheng, Jiang, Weidong, Liu, Scott
Format: Artigo
Language:Inglês
Published: Springer International Publishing 2020
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Original Research Article
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC7211197/
https://ncbi.nlm.nih.gov/pubmed/32072477
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-020-00407-0
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