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Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar.

Agarwal, Amit B

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

ISSN: 1879-0461

Standard No.: 10.1016/j.critrevonc.2016.04.016 doi

Subjects--Topical Terms:
Animals
Biosimilar Pharmaceuticals--pharmacology
Drug Evaluation, Preclinical
Erythropoietin--pharmacology
European Union
Humans
United States
United States Food and Drug Administration

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