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Biosimilar competition: lessons from Europe
Author(s) -
Henry G. Grabowski,
Rahul Guha,
Maria Salgado
Publication year - 2014
Publication title -
nature reviews drug discovery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 9.921
H-Index - 328
eISSN - 1474-1784
pISSN - 1474-1776
DOI - 10.1038/nrd4210
Subject(s) - biosimilar , filgrastim , competition (biology) , european market , medicine , pharmacology , business , international trade , ecology , biology , chemotherapy , granulocyte colony stimulating factor
Since 2005, the European Union has had a regulatory pathway through which biosimilars are approved centrally by the European Medicines Agency (EMA), as with pioneer biologics. So far, biosimilars have been approved in four separate classes: somatropins, erythropoiesis-stimulating agents (ESAs), granulocyte colony-stimulating factors (G-CSFs) and, most recently, monoclonal antibodies that are specific for tum…

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