Biosimilarity: the fda perspective
Auteur :
Niazi, Sarfaraz K.
Éditeur :
Taylor & Francis Ltd
ISBN :
9781032652351
Date de publication :
2 oct. 2023
Dimensions :
25,4 x 17,8 cm
Poids :
1000 g
Langue :
Anglais
Pays d'origine :
Grande Bretagne
The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.