Articles with "documents confirmatory" as a keyword



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AB0473 Immunogenicity of biosimilars for rheumatic diseases: an updated review from regulatory documents and confirmatory clinical trials

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Published in 2018 at "Annals of the Rheumatic Diseases"

DOI: 10.1136/annrheumdis-2018-eular.3076

Abstract: Background Several biosimilars have been approved for the treatment of rheumatic diseases by the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA). Objectives To summarise immunogenicity data from regulatory documents or… read more here.

Keywords: immunogenicity; pfizer; rheumatic diseases; documents confirmatory ... See more keywords