The challenge of indication extrapolation for infliximab biosimilars

Biologicals

Volumn 42, Issue 4, 2014, Pages 177-183

  Feagan, Brian G ^a   Choquette, Denis ^b   Ghosh, Subrata ^c   Gladman, Dafna D ^d   Ho, Vincent ^e   Meibohm, Bernd ^f   Zou, Guangyong ^a   Xu, Zhenhua ^g   Shankar, Gopi ^g   Sealey, David C ^h   Russell, Anthony S ⁱ  

^a ROBARTS RESEARCH INSTITUTE   (Canada)

^b UNIVERSITÉ DE MONTRÉAL   (Canada)

^c UNIVERSITY OF CALGARY   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

^e UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^f UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^g JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^h Janssen Inc   (Canada)

ⁱ UNIVERSITY OF ALBERTA   (Canada)

Author keywords

Biosimilars; Extrapolation; Immunogeniity; Infliximab; Monoclonal antibodies; Subsequent entry biologics

Indexed keywords

CTP 13; INFLIXIMAB; METHOTREXATE; UNCLASSIFIED DRUG; BIOSIMILAR AGENT;

ADVERSE OUTCOME; ANKYLOSING SPONDYLITIS; AREA UNDER THE CURVE; CROHN DISEASE; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG SAFETY; HEART FAILURE; HUMAN; IMMUNOGENICITY; MAXIMUM PLASMA CONCENTRATION; PNEUMONIA; PRIORITY JOURNAL; PSORIASIS VULGARIS; PSORIATIC ARTHRITIS; REVIEW; RHEUMATOID ARTHRITIS; SENSITIVITY ANALYSIS; T CELL LYMPHOMA; TREATMENT DURATION; TREATMENT OUTCOME; TUBERCULOSIS; ULCERATIVE COLITIS; ADVERSE DRUG REACTION; CANADA; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; EUROPE; FOOD AND DRUG ADMINISTRATION; IMMUNOLOGY; METABOLISM; PROCEDURES; SOUTH KOREA; STANDARDS; THERAPEUTIC EQUIVALENCE; UNITED STATES;

BIOSIMILAR PHARMACEUTICALS; CANADA; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; HUMANS; REPUBLIC OF KOREA; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84904069611     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2014.05.005     Document Type: Review

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