Biosimilar monoclonal antibodies: A science-based regulatory challenge

Expert Opinion on Biological Therapy

Volumn 13, Issue 2, 2013, Pages 153-156

  Declerck, Paul J ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

biosimilars; biotherapeutics; monoclonal antibody; regulatory

Indexed keywords

ADALIMUMAB; ALEMTUZUMAB; BASILIXIMAB; BEVACIZUMAB; BIOSIMILAR AGENT; CANAKINUMAB; CERTOLIZUMAB PEGOL; DACLIZUMAB; DENOSUMAB; GOLIMUMAB; INFLIXIMAB; MONOCLONAL ANTIBODY; OFATUMUMAB; OKT 3; PALIVIZUMAB; PANITUMUMAB; RANIBIZUMAB; RITUXIMAB; TRASTUZUMAB;

ACETYLATION; ARTICLE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; HUMAN; HYDROXYLATION; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; NONHUMAN; PROTEIN GLYCOSYLATION; PROTEIN METHYLATION; PROTEIN PHOSPHORYLATION; SULFATION;

ANTIBODIES, MONOCLONAL; ANTIBODY SPECIFICITY; BIOSIMILAR PHARMACEUTICALS; HUMANS;

EID: 84872175228     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2012.758710     Document Type: Article

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