Biosimilars: a new generation of biologics
Éditeur :
Springer Editions
ISBN :
9782817803357
Date de publication :
21 nov. 2012
Dimensions :
23,5 x 15,5 cm
Langue :
Anglais
Pays d'origine :
France
However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule†valid for small chemical entities. In response, a dedicated regulation was issued in the European Union.