Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States-Reference-Cited by-同舟云学术

Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States

Published:2017-11-20 Issue:1 Volume:103 Page:36-38
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Dougherty Michele K.¹,Zineh Issam²,Christl Leah¹

Affiliation:

1. U.S. Food and Drug Administration, Office of New Drugs, Center for Drug Evaluation and Research; Silver Spring Maryland USA

2. U.S. Food and Drug Administration, Office of Clinical Pharmacology, Center for Drug Evaluation and Research; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.909/fullpdf

Reference10 articles.

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2. USFDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product 2015 http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf

3. G-CSF: A key regulator of neutrophil production, but that's not all;Roberts;Growth Factors,2005

4. Mechanisms of G-CSF mediated hematopoietic stem and progenitor mobilization;Greenbaum;Leukemia,2011

5. Effect of escalating doses of recombinant human granulocyte colony-stimulating factor (filgrastim) on circulating neutrophils in healthy subjects;Borleffs;Clin. Ther.,1998

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