In support of the European Union biosimilar framework

Nature Biotechnology

Volumn 30, Issue 8, 2012, Pages 745-748

  Schneider, Christian K ^a,b   Borg, John J ^c   Ehmann, Falk ^d   Ekman, Niklas ^e   Heinonen, Esa ^e,f   Ho, Kowid ^g   Hoefnagel, Marcel H ^h   Van Der Plas, Roeland Martijn ^h   Ruiz, Sol ⁱ   Van Der Stappen, Antonius J ^h   Thorpe, Robin ^j   Tiitso, Klara ^d   Tsiftsoglou, Asterios S ^k   Vleminckx, Camille ^d   Waxenecker, Guenter ^l   Welin, Mats ^m   Weise, Martina ⁿ   Trouvin, Jean Hugues ^g,o  

^a Danish Health and Medicines Authority   (Denmark)

^b INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

^c Medicines Authority   (Malta)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

^e Finnish Medicines Agency (FIMEA)   (Finland)

^f Swissmedic   (Switzerland)

^g Agence Nationale de Securité du Médicament et des Produits de Santé ANSM   (France)

^h MEDICINES EVALUATION BOARD   (Netherlands)

ⁱ Spanish Medicines Agency ^*  (Spain)

^j NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^k ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^l AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY   (Austria)

^m MEDICAL PRODUCTS AGENCY   (Sweden)

ⁿ Bundesinstitut fur Arzneimittel und Medizinprodukte BfArM   (Germany)

^o UNIVERSITÉ PARIS DESCARTES   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; ERYTHROPOIETIN; GENERIC DRUG; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

BIOEQUIVALENCE; CONCEPTUAL FRAMEWORK; DRUG EFFICACY; DRUG LEGISLATION; DRUG METABOLISM; DRUG SAFETY; EUROPEAN BIOSIMILAR REGULATION; HUMAN; LETTER; NONHUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL PROCEDURES;

BIOPHARMACEUTICS; HUMANS; LEGISLATION, DRUG;

EID: 84864871547     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2322     Document Type: Letter

References (17)

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