Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar. [electronic resource]
- Critical reviews in oncology/hematology Aug 2016
- 98-107 p. digital
Publication Type: Journal Article; Review
1879-0461
10.1016/j.critrevonc.2016.04.016 doi
Animals Biosimilar Pharmaceuticals--pharmacology Drug Evaluation, Preclinical Erythropoietin--pharmacology European Union Humans United States United States Food and Drug Administration