The regulatory framework of biosimilars in the European Union

Drug Discovery Today

Volumn 17, Issue 1-2, 2012, Pages 63-70

  Minghetti, Paola ^a   Rocco, Paolo ^a   Cilurzo, Francesco ^a   Del Vecchio, Lucia ^b   Locatelli, Francesco ^b  

^a UNIVERSITY OF MILAN   (Italy)

^b A MANZONI HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; HUMAN GROWTH HORMONE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SB 309; UNCLASSIFIED DRUG;

ANEMIA; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW;

BIOLOGICAL AGENTS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; EUROPEAN UNION; HUMANS;

EID: 84855831175     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2011.08.001     Document Type: Review

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