Biosimilars and the european experience: Implications for the United States

Health Affairs

Volumn 32, Issue 10, 2013, Pages 1803-1810

  Megerlin, Francis ^a,b   Lopert, Ruth ^c,d   Taymor, Ken ^e   Trouvin, Jean Hugues ^f  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b School of Public Health   (United States)

^c GEORGE WASHINGTON UNIVERSITY   (United States)

^d THERAPEUTIC GOODS ADMINISTRATION   (Australia)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; ERYTHROPOIETIN; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; LOW MOLECULAR WEIGHT HEPARIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN; VACCINE;

ANEMIA; ARTICLE; AUTHORITY; CHRONIC KIDNEY FAILURE; COST; DRUG EFFICACY; DRUG EXPOSURE; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ERYTHROPOIESIS; EUROPEAN UNION; EXPIRATION DATE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; PATENT; POLICY; PRACTICE GUIDELINE; REIMBURSEMENT; RISK MANAGEMENT; STANDARD; TREATMENT DURATION; UNITED STATES; DRUG LEGISLATION; ECONOMICS; EUROPE;

BIOSIMILAR PHARMACEUTICALS; EUROPE; LEGISLATION, DRUG; PHARMACOVIGILANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84885403899     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2009.0196     Document Type: Article

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