Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment

Background SB3 has been developed as a trastuzumab biosimilar, a therapeutic monoclonal antibody targeted to human epidermal growth factor receptor 2 (HER2), and approved by the European Commission and United States (US) Food and Drug Administration (FDA). During the developmental period of a biosim...

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Veröffentlicht in:	BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2019-08, Vol.33 (4), p.411-422
Hauptverfasser:	Lee, Jae Hee, Paek, Kyungyeol, Moon, Jae Hyon, Ham, Sunyoung, Song, Jinsu, Kim, Seokkyun
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies Antineoplastic Agents, Immunological - pharmacology Antineoplastic Agents, Immunological - therapeutic use Biological Assay - standards Biological products Biomedical and Life Sciences Biomedicine Biosimilar Pharmaceuticals - pharmacology Biosimilar Pharmaceuticals - therapeutic use Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - pathology Cancer Research Cancer therapies Cell growth Cell Line Cell Line, Tumor Drug Screening Assays, Antitumor - standards Epidermal growth factor ErbB-2 protein FDA approval Humans Immunotherapy Kinases Manufacturers Molecular Medicine Monoclonal antibodies Original Original Research Article Pharmacotherapy Proteins Receptor, ErbB-2 - antagonists & inhibitors Receptor, ErbB-2 - metabolism Reference Standards Software Targeted cancer therapy Trastuzumab Trastuzumab - pharmacology Trastuzumab - therapeutic use
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