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Biosimilars: Evidential Standards for Health Technology Assessment

2010; Wiley; Volume: 87; Issue: 3 Linguagem: Inglês

10.1038/clpt.2009.112

1532-6535

Dyfrig Hughes,

Pharmaceutical studies and practices

Clinical Pharmacology & TherapeuticsVolume 87, Issue 3 p. 257-261 Point/Counterpoint Biosimilars: Evidential Standards for Health Technology Assessment D A Hughes, Corresponding Author D A Hughes [email protected] Centre for Economics and Policy in Health, Institute of Medical and Social Care Research, Bangor University, Bangor, Wales, UKSearch for more papers by this author D A Hughes, Corresponding Author D A Hughes [email protected] Centre for Economics and Policy in Health, Institute of Medical and Social Care Research, Bangor University, Bangor, Wales, UKSearch for more papers by this author First published: 09 December 2009 https://doi.org/10.1038/clpt.2009.112Citations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat References 1Lanthier, M., Behrman, R. & Nardinelli, C. Economic issues with follow-on protein products. Nat. Rev. Drug Discov. 7, 733–7 (2008). 2Schneider, C.K. & Kalinke, U. Toward biosimilar monoclonal antibodies. Nat. Biotechnol. 26, 985–990 (2008). 3Kresse, G.-B. Biosimilars—science, status, and strategic perspective. Eur. J. Pharm. Biopharm. 72, 479–486 (2009). 4De Groot, A.S. & Scott, D.W. Immunogenicity of protein therapeutics. Trends Immunol. 28, 482–490 (2007). 5Sorensen, P.S. et al. Danish Multiple Sclerosis Study Group. Clinical importance of neutralising antibodies against interferon beta in patients with relapsing-remitting multiple sclerosis. Lancet 362, 1184–1191 (2003). 6Keithi-Reddy, S.R., Kandasamy, S., & Singh, A.K. Pure red cell aplasia due to follow-on epoetin. Kidney Int. 74, 1617–1622 (2008). 7Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (2004). 8 European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. EMEA/CHMP/BWP/49348/2005 (22 February 2006). 9 European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on Similar Biological Medicinal Products. CHMP/437/04 (30 October 2005). 10 Committee for Medicinal Products for Human Use. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. EMEA/CHMP/BMWP/14327/2006 (13 December 2007). 11 European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. EMEA/CHMP/BMWP/42832/2005 (22 February 2006). 12 National Institute for Health and Clinical Excellence. Published Technology Appraisals . Accessed 28 April 2009. 13 Joint Formulary Committee. British National Formulary, 57th edn. (British Medical Association and Royal Pharmaceutical Society of Great Britain, London, 2009). 14 Scottish Medicines Consortium. Epoetin Zeta (Retacrit) for Treatment of Anaemia Associated with Chronic Renal Failure (2008). Accessed 28 April 2009. 15Simoens, S. Interchangeability of off-patent medicines: a pharmacoeconomic perspective. Expert Rev. Pharmacoeconomics Outcomes Res. 8, 519–526 (2008). 16Briggs, A.H. & O'Brien, B.J. The death of cost-minimization analysis? Health Econ. 10, 179–184 (2001). 17 European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on Comparability of Biotechnology-Derived Medicinal Products After a Change in the Manufacturing Process: Non-Clinical and Clinical Issues. EMEA/CHMP/BMWP/101695/2006 (19 July 2007). 18Bosmans, J.E., deBruijne, M.C., vanHout, H.P., Hermens, M.L., Adèr, H.J. & vanTulder, M.W. Practical guidelines for economic evaluations alongside equivalence trials. Value Health. 11, 251–258 (2008). 19Horton, L.R. The European Experience with Follow-on Biologics Legislation. Federal Trade Commission Roundtable on Follow-on Biologic Drugs: Framework for Competition and Continued Innovation (21 November 2008). 20Ferner, R.E., Hughes, D.A. & Aronson, J.K. NICE and new: appraising innovation. BMJ 340, b5493 (2010). 21 Medicines and Healthcare Products Regulatory Agency and the Commission on Human Medicines. Biosimilar products: what is biosimilar? Drug Safety Update. 1, 8 (2008) . Citing Literature Volume87, Issue3Drug Discovery & DevelopmentMarch 2010Pages 257-261 ReferencesRelatedInformation