Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel®)

Expert Opinion on Biological Therapy

Volumn 16, Issue 10, 2016, Pages 1185-1195

  Hofmann, Hans Peter ^a   Kronthaler, Ulrich ^a   Fritsch, Cornelius ^b   Grau, Roger ^b   Müller, Stefan O ^a   Mayer, Robert ^b   Seidl, Andreas ^a   Da Silva, Antonio ^a  

^a Sandoz Biopharmaceuticals   (Germany)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

biosimilars; disease modifying drugs; Enbrel; etanercept; GP2015; TNF

Indexed keywords

BIOSIMILAR AGENT; COMPLEMENT COMPONENT C1Q; ETANERCEPT; FC RECEPTOR; GP 2015; TUMOR NECROSIS FACTOR; UNCLASSIFIED DRUG; ANTIRHEUMATIC AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; AREA UNDER THE CURVE; ARTICLE; BINDING AFFINITY; BIOEQUIVALENCE; COMPARATIVE STUDY; COMPLEMENT DEPENDENT CYTOTOXICITY; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CYTOTOXICITY; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MECHANISM; DRUG PROTEIN BINDING; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG SCREENING; ELIMINATION HALF-LIFE; EXPERIMENTAL RABBIT; FEMALE; HUMAN; HUMAN CELL; IN VITRO STUDY; IN VIVO STUDY; MACACA FASCICULARIS; MALE; MAXIMUM PLASMA CONCENTRATION; MOUSE; NONHUMAN; PHARMACODYNAMICS; PILOT STUDY; PLASMA CONCENTRATION-TIME CURVE; POLYARTHRITIS; PRECLINICAL STUDY; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; ANIMAL; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; CHEMISTRY; METABOLISM;

ANIMALS; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; ETANERCEPT; HUMANS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84982103457     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1080/14712598.2016.1217329     Document Type: Article

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