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Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory

Alex Kudrin1, Ivana Knezevic2, Jeewon Joung3

  • 1Celltrion Inc, Incheon, Republic of Korea.

Biologicals : Journal of the International Association of Biological Standardization
|December 4, 2014
PubMed

Keywords:
BiosimilarClinical assessmentEquivalenceExtrapolationSimilar biotherapeutic productsWHO

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