Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents.

@article{Vezr2016AuthorizedMC,
  title={Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents.},
  author={Bal{\'a}zs Vez{\'e}r and Zsuzsanna Buz{\'a}s and Mikl{\'o}s Sebeszta and Zsombor Zrubka},
  journal={Current medical research and opinion},
  year={2016},
  volume={32 5},
  pages={829-34}
}
Background The quality of biologicals, including biosimilars, is subject to change as a result of manufacturing process modifications following initial authorization. It is important that such product changes have no adverse impact on product efficacy or safety, including immunogenicity. Objectives The aim of this study was to investigate the number and types of manufacturing changes for originator mAbs (the reference for the comparability exercise to confirm biosimilarity) according to… CONTINUE READING
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