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

Current Medical Research and Opinion

Volumn 32, Issue 5, 2016, Pages 829-834

  Vezér, Balázs ^a   Buzás, Zsuzsanna ^a   Sebeszta, Miklós ^a   Zrubka, Zsombor ^a  

^a EGIS PHARMACEUTICALS LTD   (Hungary)

Author keywords

Biologicals; Biosimilarity; Biosimilars; Comparability; European Public Assessment Report; Manufacturing; Monoclonal antibodies

Indexed keywords

ADALIMUMAB; BASILIXIMAB; BIOSIMILAR AGENT; ECULIZUMAB; INFLIXIMAB; MONOCLONAL ANTIBODY; PERTUZUMAB; TRASTUZUMAB;

ARTICLE; DRUG APPROVAL; DRUG MANUFACTURE; DRUG MARKETING; EUROPEAN MEDICINES AGENCY; EUROPEAN PUBLIC ASSESSMENT REPORT; MEDICAL DOCUMENTATION; HUMAN;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; HUMANS;

EID: 84959042048     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2016.1145579     Document Type: Article

References (13)

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