Biosimilar infliximab for inflammatory bowel disease: From concepts to clinical practice. Case study illustrated with CT-P13

Expert Review of Gastroenterology and Hepatology

Volumn 9, Issue , 2015, Pages 5-15

  Schreiber, Stefan ^a   Panés, Julian ^b   Kwon, ByoungOh ^c   Hong, SeungSuh ^c   Peyrin Biroulet, Laurent ^d  

^a UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^b INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^c Celltrion Inc   (South Korea)

^d UNIVERSITY HOSPITAL OF NANCY   (France)

Author keywords

biosimilar; CT P13; extrapolation; infliximab; manufacture; regulatory approval

Indexed keywords

FILGRASTIM; INFLIXIMAB; RECOMBINANT ERYTHROPOIETIN; ANTIINFLAMMATORY AGENT; BIOSIMILAR AGENT; CT-P13; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR ALPHA;

ANKYLOSING SPONDYLITIS; AREA UNDER THE CURVE; CASE STUDY; CLINICAL PRACTICE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG MANUFACTURE; DRUG MECHANISM; DRUG RESEARCH; DRUG SAFETY; HUMAN; INFLAMMATORY BOWEL DISEASE; MAXIMUM PLASMA CONCENTRATION; PHYSICAL CHEMISTRY; POSTMARKETING SURVEILLANCE; REVIEW; RHEUMATOID ARTHRITIS; SIDE EFFECT; ANIMAL; ANTAGONISTS AND INHIBITORS; IMMUNOLOGY; INFLAMMATORY BOWEL DISEASES; THERAPEUTIC EQUIVALENCE; TREATMENT OUTCOME;

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

EID: 84942324007     PISSN: 17474124     EISSN: 17474132     Source Type: Journal    
DOI: 10.1586/17474124.2015.1091304     Document Type: Review

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