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

@article{Xu2019PhysicochemicalAF,
  title={Physicochemical and functional assessments demonstrating analytical similarity between rituximab biosimilar HLX01 and the MabThera®},
  author={Yanpeng Xu and Liqi Xie and Erhui Zhang and Wenyuan Gao and L. Wang and Y. Cao and M. H. Xie and Weidong Jiang and S. Liu},
  journal={mAbs},
  year={2019},
  volume={11},
  pages={606 - 620}
}
  • Yanpeng Xu, Liqi Xie, +6 authors S. Liu
  • Published 2019
  • Medicine, Biology
  • mAbs
  • ABSTRACT 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 biosimilar guidelines and requirements, was the first such drug submitted for regulatory review in China, and it is expected to receive approval there as a biosimilar product. To demonstrate… CONTINUE READING
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