Development and regulation of biosimilars: Current status and future challenges

BioDrugs

Volumn 27, Issue 3, 2013, Pages 203-211

  Tsiftsoglou, Asterios S ^a   Ruiz, Sol ^b   Schneider, Christian K ^c,d  

^a ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^b Spanish Medicines Agency ^*  (Spain)

^c Danish Health and Medicines Authority   (Denmark)

^d INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; ADALIMUMAB; BETA1A INTERFERON; BEVACIZUMAB; BIOSIMILAR AGENT; EXENDIN 4; HUMAN GROWTH HORMONE; INFLIXIMAB; INSULIN ASPART; INSULIN GLARGINE; INSULIN LISPRO; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PALIVIZUMAB; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; TRASTUZUMAB;

BIOLOGICAL ACTIVITY; DRUG EFFICACY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SAFETY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; PATENT; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; RISK BENEFIT ANALYSIS;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; DRUG SUBSTITUTION; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; PATENTS AS TOPIC; RECOMBINANT PROTEINS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84878536093     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-013-0020-y     Document Type: Review

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