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Volumn 87, Issue 3, 2010, Pages 257-261

Biosimilars: Evidential standards for health technology assessment

Author keywords

[No Author keywords available]

Indexed keywords

ABSEAMED; ALPHEON; BIOGRASTIM; DOCETAXEL; DOXORUBICIN; HEXAL; HUMAN GROWTH HORMONE; HUMAN INSULIN; ISOPHANE INSULIN; LOW MOLECULAR WEIGHT HEPARIN; RATIOGRASTIM; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TEVAGRASTIM; UNCLASSIFIED DRUG; ZARZIO;

EID: 77149122380     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.112     Document Type: Review
Times cited : (13)

References (21)
  • 2
    • 51349137409 scopus 로고    scopus 로고
    • Toward biosimilar monoclonal antibodies
    • Schneider, C.K. & Kalinke, U. Toward biosimilar monoclonal antibodies. Nat. Biotechnol. 26, 985-990 (2008).
    • (2008) Nat. Biotechnol. , vol.26 , pp. 985-990
    • Schneider, C.K.1    Kalinke, U.2
  • 3
    • 67449138587 scopus 로고    scopus 로고
    • Biosimilars-science status, and strategic perspective
    • Kresse, G.-B. Biosimilars-science, status, and strategic perspective. Eur. J. Pharm. Biopharm. 72, 479-486 (2009).
    • (2009) Eur. J. Pharm. Biopharm. , vol.72 , pp. 479-486
    • Kresse, G.-B.1
  • 4
    • 36049006592 scopus 로고    scopus 로고
    • Immunogenicity of protein therapeutics
    • De Groot, A.S. & Scott, D.W. Immunogenicity of protein therapeutics. Trends Immunol. 28, 482-490 (2007).
    • (2007) Trends Immunol. , vol.28 , pp. 482-490
    • De Groot, A.S.1    Scott, D.W.2
  • 5
    • 10744225329 scopus 로고    scopus 로고
    • Clinical importance of neutralising antibodies against interferon beta in patients with relapsing-remitting multiple sclerosis
    • Sorensen, 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).
    • (2003) Lancet , vol.362 , pp. 1184-1191
    • Sorensen, P.S.1
  • 6
    • 57049111999 scopus 로고    scopus 로고
    • Pure red cell aplasia due to follow-on epoetin
    • Keithi-Reddy, S.R., Kandasamy, S., & Singh, A.K. Pure red cell aplasia due to follow-on epoetin. Kidney Int. 74, 1617-1622 (2008)
    • (2008) Kidney Int. , vol.74 , pp. 1617-1622
    • Keithi-Reddy, S.R.1    Kandasamy, S.2    Singh, A.K.3
  • 7
    • 77149135032 scopus 로고    scopus 로고
    • Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004
    • Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (2004).
    • (2004)
  • 8
    • 33645689280 scopus 로고    scopus 로고
    • European Medicines Agency Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. EMEA/CHMP/ BWP/49348/ 22 February 2006
    • 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).
    • (2005) Committee for Medicinal Products for Human Use
  • 9
    • 25844468887 scopus 로고    scopus 로고
    • European Medicines Agency Guideline on Similar Biological Medicinal Products. CHMP/437/04 30 October 2005
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on Similar Biological Medicinal Products. CHMP/437/04 (30 October 2005).
    • Committee for Medicinal Products for Human Use
  • 10
    • 25844468887 scopus 로고    scopus 로고
    • Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. EMEA/CHMP/BMWP/14327/ 13 December 2007
    • Committee for Medicinal Products for Human Use. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. EMEA/CHMP/BMWP/14327/2006 (13 December 2007).
    • (2006) Committee for Medicinal Products for Human Use
  • 11
    • 33645689280 scopus 로고    scopus 로고
    • European Medicines Agency Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. EMEA/CHMP/BMWP/42832/ 22 February 2006
    • 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).
    • (2005) Committee for Medicinal Products for Human Use
  • 12
    • 77149149485 scopus 로고    scopus 로고
    • National Institute for Health and Clinical Excellence. Published Technology Appraisals Accessed 28 April
    • National Institute for Health and Clinical Excellence. Published Technology Appraisals. Accessed 28 April 2009.
    • (2009)
  • 13
    • 25844453682 scopus 로고    scopus 로고
    • Joint Formulary Committee 57th edn. (British Medical Association and Royal Pharmaceutical Society of Great Britain, London
    • Joint Formulary Committee. British National Formulary, 57th edn. (British Medical Association and Royal Pharmaceutical Society of Great Britain, London, 2009).
    • (2009) British National Formulary
  • 14
    • 77149133489 scopus 로고    scopus 로고
    • Scottish Medicines Consortium Epoetin Zeta (Retacrit) for Treatment of Anaemia Associated with Chronic Renal Failure Accessed 28 April 2009
    • Scottish Medicines Consortium. Epoetin Zeta (Retacrit) for Treatment of Anaemia Associated with Chronic Renal Failure (2008). Accessed 28 April 2009.
    • (2008)
  • 15
    • 68649109853 scopus 로고    scopus 로고
    • Interchangeability of off-patent medicines: A pharmacoeconomic perspective
    • Simoens, S. Interchangeability of off-patent medicines: a pharmacoeconomic perspective. Expert Rev. Pharmacoeconomics Outcomes Res. 8, 519-526 (2008).
    • (2008) Expert Rev. Pharmacoeconomics Outcomes Res. , vol.8 , pp. 519-526
    • Simoens, S.1
  • 16
    • 0035061971 scopus 로고    scopus 로고
    • The death of cost-minimization analysis?
    • Briggs, A.H. & O'Brien, B.J. The death of cost-minimization analysis? Health Econ. 10, 179-184 (2001).
    • (2001) Health Econ. , vol.10 , pp. 179-184
    • Briggs, A.H.1    O'Brien, B.J.2
  • 17
    • 25844468887 scopus 로고    scopus 로고
    • European Medicines Agency Guideline on Comparability of Biotechnology-Derived Medicinal Products After a Change in the Manufacturing Process: Non-Clinical and Clinical Issues EMEA/ CHMP/BMWP/101695 19 July 2007
    • 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).
    • (2006) Committee for Medicinal Products for Human Use
  • 20
    • 75749111380 scopus 로고    scopus 로고
    • NICE and new: Appraising innovation
    • Ferner, R.E., Hughes, D.A. & Aronson, J.K. NICE and new: appraising innovation. BMJ 340, b5493 (2010).
    • (2010) BMJ , vol.340 , Issue.5493
    • Ferner, R.E.1    Hughes, D.A.2    Aronson, J.K.3
  • 21
    • 54949139961 scopus 로고    scopus 로고
    • Biosimilar products: What is biosimilar?
    • Medicines and Healthcare Products Regulatory Agency and the Commission on Human Medicines
    • Medicines and Healthcare Products Regulatory Agency and the Commission on Human Medicines. Biosimilar products: what is biosimilar? Drug Safety Update. 1, 8 (2008).
    • (2008) Drug Safety Update. , vol.1 , pp. 8


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.