Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®

  title={Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®},
  author={Erhui Zhang and Liqi Xie and Peilan Qin and L. Lu and Yanpeng Xu and W. Gao and L. Wang and M. H. Xie and Weidong Jiang and S. Liu},
  journal={The AAPS Journal},
  • Erhui Zhang, Liqi Xie, +7 authors S. Liu
  • Published 2020
  • Mathematics, Medicine
  • The AAPS Journal
  • Quality by design (QbD) is an efficient but challenging approach for the development of biosimilar due to the complex relationship among process, quality, and efficacy. Here, the analytical similarity of adalimumab biosimilar HLX03 to Humira® was successfully established following a QbD quality study. Quality target product profile (QTPP) of HLX03 was first generated according to the public available information and initial characterization of 3 batches of Humira®. The critical quality… CONTINUE READING
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