Contribution of animal studies to evaluate the similarity of biosimilars to reference products

Drug Discovery Today

Volumn 20, Issue 4, 2015, Pages 483-490

  Van Meer, Peter J K ^a,b   Ebbers, Hans C ^a   Kooijman, Marlous ^c   Gispen De Wied, Christine C ^b   Silva Lima, Beatriz ^d   Moors, Ellen H M ^c   Schellekens, Huub ^a,c  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

^d RESEARCH INSTITUTE FOR MEDICINES IMED ULISBOA   (Portugal)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; CT P 13; EP 2000; EP 2006; FILGRASTIM; HUMAN GROWTH HORMONE; HUMAN INSULIN; INFLIXIMAB; INSULIN GLARGINE; LBD 009; PLD 108; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT FOLLITROPIN; SB 309; UNCLASSIFIED DRUG; XM 02; XM 17;

ANTIBODY PRODUCTION; BIOLOGICAL ACTIVITY; DRUG BINDING; DRUG EFFICACY; DRUG LEGISLATION; DRUG MARKETING; DRUG MECHANISM; DRUG POTENCY; DRUG RECEPTOR BINDING; DRUG SAFETY; IMMUNOGENICITY; NONHUMAN; PRACTICE GUIDELINE; REVIEW; SYSTEMATIC REVIEW; ANIMAL; ANIMAL MODEL; DRUG APPROVAL; DRUG SCREENING; EUROPEAN UNION; HUMAN; PROCEDURES; QUALITY CONTROL; RISK ASSESSMENT; SPECIES DIFFERENCE; STANDARDS; TOXICITY TESTING;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS; MODELS, ANIMAL; QUALITY CONTROL; RISK ASSESSMENT; SPECIES SPECIFICITY; TOXICITY TESTS;

EID: 84928723272     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2014.11.009     Document Type: Review

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