State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists

Author:

Covic Adrian,Abraham Ivo

Publisher

Springer Science and Business Media LLC

Subject

Urology,Nephrology

Reference59 articles.

1. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, Moreau A, Narayanan G, Kruse NA, Reichmann G, Thorpe R, van Aerts L, Vleminckx C, Wadhwa M, Schneider CK (2012) Biosimilars: what clinicians should know. Blood 120:5111–5117

2. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK (2014) Biosimilars: the science of extrapolation. Blood 124:3191–3196

3. Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (2012) US Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf . Accessed 21 Jan 2014

4. Guidance for Industry Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (2012) US Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf . Accessed 21 Jan 2014

5. Guideline on Non-Clinical and Clinical Development of Similar Biologic Medicinal Products Containing Recombinant Erythropoietins (Revision) (2010) European Medicines Agency Committee for Medicinal Products for Human Use. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089474.pdf . Accessed 21 Jan 2014

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