Pharmacovigilance and biosimilars: Considerations, needs and challenges

Expert Opinion on Biological Therapy

Volumn 13, Issue 7, 2013, Pages 1039-1047

  Casadevall, Nicole ^a   Edwards, I Ralph ^b   Felix, Thomas ^c   Graze, Peter R ^d   Litten, Jason B ^c   Strober, Bruce E ^e   Warnock, David G ^f  

^a HÔPITAL SAINT ANTOINE   (France)

^b UPPSALA MONITORING CENTRE   (Sweden)

^c AMGEN INC   (United States)

^d DeCesaris Cancer Institute   (United States)

^e UNIVERSITY OF CONNECTICUT SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

Biosimilar; Follow on biologic; Pharmacovigilance; Reference product; Safety; Similar biologic medicinal products; Similar biotherapeutic; Traceability

Indexed keywords

ANTIANEMIC AGENT; BIOSIMILAR AGENT; ERYTHROPOIETIN; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; NEUTRALIZING ANTIBODY; RECOMBINANT ERYTHROPOIETIN;

BIOEQUIVALENCE; CHRONIC KIDNEY DISEASE; CHRONIC KIDNEY FAILURE; DECISION MAKING; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HUMAN; IMMUNOGENICITY; MANDATORY REPORTING; MEDICAL DECISION MAKING; MEDICAL RECORD; MEDICATION ERROR; NOMENCLATURE; PATIENT CARE; PATIENT MONITOR; PATIENT SAFETY; POTENTIAL DIFFERENCE; PROSPECTIVE STUDY; PURE RED CELL ANEMIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; THAILAND; UNITED STATES; VOLUNTARY REPORTING; WORLD HEALTH ORGANIZATION;

BIOSIMILAR PHARMACEUTICALS; HUMANS; PHARMACOVIGILANCE; THERAPEUTIC EQUIVALENCY;

EID: 84878900689     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2013.783560     Document Type: Review

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