Demonstration of Functional Similarity of Proposed Biosimilar ABP 501 to Adalimumab

@inproceedings{Velayudhan2016DemonstrationOF,
  title={Demonstration of Functional Similarity of Proposed Biosimilar ABP 501 to Adalimumab},
  author={Jyoti Velayudhan and Yuh-feng Chen and Amanda Rohrbach and Christina Pastula and Gwen Maher and Heather Marie Thomas and R. Philip Brown and Teresa L. Born},
  booktitle={BioDrugs},
  year={2016}
}
Due to the complex molecular structure and proprietary manufacturing processes of monoclonal antibodies (mAbs), differences in structure and function may be expected during development of biosimilar mAbs. Important regulatory requirements for approval of biosimilar products involve comprehensive assessments of any potential differences between proposed biosimilars and reference mAbs, including differences in all known mechanisms of action, using sensitive and relevant methods. Any identified… CONTINUE READING
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