Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280014 and Trastuzumab (Herceptin®)
2014
Background and Objectives
Trastuzumab(Herceptin®) is a humanized monoclonal antibody (mAb) that binds to the HER2 protein. PF-05280014 is being developed as a potential
biosimilarto
trastuzumab
products marketedin the United States (
trastuzumab-US) and European Union (
trastuzumab-EU). Nonclinical studies were designed to evaluate the similarity of PF-05280014 to
trastuzumab-US and
trastuzumab-EU using in vitro structural and functional analyses, and in vivo pharmacokinetic and immunogenicity assessments.
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