Setting the stage for biosimilar monoclonal antibodies

Nature Biotechnology

Volumn 30, Issue 12, 2012, Pages 1179-1185

  Schneider, Christian K ^a   Vleminckx, Camille ^b   Gravanis, Iordanis ^b   Ehmann, Falk ^b   Trouvin, Jean Hugues ^b,c   Weise, Martina ^b,d   Thirstrup, Steffen ^a,e  

^a Danish Health and Medicines Authority   (Denmark)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte   (Germany)

^e UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

BETA INTERFERON; BIOSIMILAR AGENT; ERYTHROPOIETIN; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; HUMAN GROWTH HORMONE; HYBRID PROTEIN; INFLIXIMAB; INSULIN; INSULIN DERIVATIVE; LOW MOLECULAR WEIGHT HEPARIN; MONOCLONAL ANTIBODY; RECOMBINANT ALPHA INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN;

CONCEPTUAL FRAMEWORK; DRUG APPROVAL; DRUG INDICATION; DRUG INDUSTRY; DRUG MARKETING; DRUG QUALITY; EUROPE; GOVERNMENT REGULATION; HUMAN; LICENSING; NONHUMAN; NOTE; PRACTICE GUIDELINE; PRIORITY JOURNAL;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; BIOTECHNOLOGY; DRUG APPROVAL; DRUG LABELING; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS;

EID: 84870935790     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2447     Document Type: Note

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