The continuum of comparability extends to biosimilarity: How much is enough and what clinical data are necessary?

Clinical Pharmacology and Therapeutics

Volumn 93, Issue 4, 2013, Pages 315-317

  McCamish, M ^a   Woollett, G ^b  

^a Sandoz International   (Germany)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; ETANERCEPT; HUMAN GROWTH HORMONE; MONOCLONAL ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB;

ARTICLE; COMPARATIVE STUDY; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOGENICITY; OUTCOME ASSESSMENT; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; UNITED STATES;

BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; HUMANS;

EID: 84875477617     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.17     Document Type: Article

References (5)

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