Physicochemical and functional assessments demonstrating analytical similarity between rituximab biosimilar HLX01 and the MabThera®

Development of bio-therapeutics has exhibited exponential growth in China over the past decade. However, no biosimilar drug has been approved in China (CN) due to the lack of a national biosimilar regulatory guidance. HLX01, a rituximab biosimilar developed in China under European Medicines Agency b...

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Bibliographische Detailangaben
Veröffentlicht in:MAbs
Hauptverfasser: Xu, Yanpeng, Xie, Liqi, Zhang, Erhui, Gao, Wenyuan, Wang, Linlin, Cao, Yang, Xie, Michael Hongwei, Jiang, Weidong, Liu, Scott
Format: Artigo
Sprache:Inglês
Veröffentlicht: Taylor & Francis 2019
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Report
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6512903/
https://ncbi.nlm.nih.gov/pubmed/30794092
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19420862.2019.1578147
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