Biosimilar granulocyte-colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?

Author:

Bonig Halvard1,Becker Petra S.2,Schwebig Arnd3,Turner Matthew4

Affiliation:

1. Department for Translational Development of Cellular Therapeutics; Institute for Transfusion Medicine and Immunohematology; Johann-Wolfgang-Goethe University Medical School

2. Department of Transplantation Immunology and Immunogenetics; German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute Frankfurt; Frankfurt Germany

3. Hexal AG

4. Sandoz International GmbH; Holzkirchen Germany

Publisher

Wiley

Subject

Hematology,Immunology,Immunology and Allergy

Reference69 articles.

1. European Medicines Agency Scientific guidelines on biosimilar medicines 2005-2013 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c

2. Food and Drug Administration (FDA) Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product 2012 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128

3. Australian Therapeutic Goods Administration (TGA) Evaluation of biosimilars 2013 http://www.tga.gov.au/pdf/pm-argpm-biosimilars.pdf

4. Biosimilars: it's not as simple as cost alone;Roger;J Clin Pharm Ther,2008

5. KDIGO clinical practice guideline for anemia in chronic kidney disease;Kidney Disease Improving Global Outcomes (KDIGO) Anemia Work Group;Kidney Int Suppl,2012

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