The scientific and regulatory rationale for indication extrapolation: A case study based on the infliximab biosimilar CT-P13

Expert Review of Gastroenterology and Hepatology

Volumn 9, Issue , 2015, Pages 17-26

  Reinisch, Walter ^a   Louis, Edouard ^b   Danese, Silvio ^c  

^a MCMASTER UNIVERSITY   (Canada)

^b UNIVERSITY OF LIÈGE   (Belgium)

^c HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

Author keywords

biosimilar; CT P13; extrapolation; inflammatory bowel disease; infliximab; mechanism of action; pharmacokinetics

Indexed keywords

INFLIXIMAB; TUMOR NECROSIS FACTOR; TUMOR NECROSIS FACTOR INHIBITOR; ANTIINFLAMMATORY AGENT; BIOSIMILAR AGENT; CT-P13; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR ALPHA;

AREA UNDER THE CURVE; BINDING AFFINITY; CASE STUDY; CROHN DISEASE; CYTOTOXICITY; DRUG CLEARANCE; DRUG CONTROL; DRUG DISTRIBUTION; DRUG INDICATION; DRUG MECHANISM; DRUG PROTEIN BINDING; HUMAN; INFLAMMATORY BOWEL DISEASE; INFLAMMATORY DISEASE; MACROPHAGE; MAXIMUM PLASMA CONCENTRATION; PATHOGENESIS; PHYSICAL CHEMISTRY; REVIEW; SIGNAL TRANSDUCTION; ULCERATIVE COLITIS; WOUND HEALING; ANIMAL; ANTAGONISTS AND INHIBITORS; DRUG APPROVAL; IMMUNOLOGY; INFLAMMATORY BOWEL DISEASES; THERAPEUTIC EQUIVALENCE; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

ANIMALS; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; GASTROINTESTINAL AGENTS; HUMANS; INFLAMMATORY BOWEL DISEASES; INFLIXIMAB; THERAPEUTIC EQUIVALENCY; TISSUE DISTRIBUTION; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84942307684     PISSN: 17474124     EISSN: 17474132     Source Type: Journal    
DOI: 10.1586/17474124.2015.1091306     Document Type: Review

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