Similar Biological Medicinal Products Containing Recombinant Human Growth Hormone: European Regulation

The concept of similar biological medicinal products (‘biosimilar’ medicinal products) allows pharmaceutical companies to develop products based on an abridged dossier once the marketing protection of the ‘reference’ biological medicinal product has expired. A biosimilar medicinal product can be gra...

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Veröffentlicht in:	Hormone research 2008-01, Vol.69 (1), p.14-21
Hauptverfasser:	Pavlovic, Mira, Girardin, Elizabeth, Kapetanovic, Liliana, Ho, Kowid, Trouvin, Jean-Hugues
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological Products - standards Drug Approval - legislation & jurisprudence European Union Growth Hormone - standards Human Growth Hormone - standards Humans Legislation, Drug Mini Review
Online-Zugang:	Volltext
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