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Volumn 20, Issue 5, 2013, Pages 275-286

How to select a biosimilar

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; EPOETIN ALPHA HEXAL; HUMAN GROWTH HORMONE; MONOCLONAL ANTIBODY; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; UNCLASSIFIED DRUG;

EID: 84884366767     PISSN: 20479956     EISSN: 20479964     Source Type: Journal    
DOI: 10.1136/ejhpharm-2013-000370     Document Type: Article
Times cited : (18)

References (56)
  • 1
    • 84884381595 scopus 로고    scopus 로고
    • European Commission, European Commission, accessed 3 Jul 2013
    • European Commission. What you need to know about biosimilar medicinal products. European Commission. 2013. http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf (accessed 3 Jul 2013).
    • (2013) What You Need to Know About Biosimilar Medicinal Products
  • 2
    • 84885377323 scopus 로고    scopus 로고
    • A European perspective on the market accessibility of biosimilars
    • Declerck PJ, Simoens S. A European perspective on the market accessibility of biosimilars. Biosimilars 2012;2:33-40.
    • (2012) Biosimilars , vol.2 , pp. 33-40
    • Declerck, P.J.1    Simoens, S.2
  • 3
    • 77949469515 scopus 로고    scopus 로고
    • Are biosimilars really generics?
    • Misra A. Are biosimilars really generics? Expert Opin Biol Ther 2010;10:489-94.
    • (2010) Expert Opin Biol Ther , vol.10 , pp. 489-494
    • Misra, A.1
  • 4
    • 48949118414 scopus 로고    scopus 로고
    • Points to consider in the evaluation of biopharmaceuticals
    • Krämer I, Tredree R, Vulto A. Points to consider in the evaluation of biopharmaceuticals. Eur J Hosp Pharm Prac 2008;14:73-6.
    • (2008) Eur J Hosp Pharm Prac , vol.14 , pp. 73-76
    • Krämer, I.1    Tredree, R.2    Vulto, A.3
  • 5
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing biological products and assessing comparability following manufacturing changes
    • Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotech 2006;22:1383-91.
    • (2006) Nat Biotech , vol.22 , pp. 1383-1391
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 6
    • 19044374719 scopus 로고    scopus 로고
    • Biosimilar epoetins: How similar are they?
    • Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm 2004;3:43-7.
    • (2004) Eur J Hosp Pharm , vol.3 , pp. 43-47
    • Schellekens, H.1
  • 7
    • 79952534748 scopus 로고    scopus 로고
    • Taking immunogenicity assessment of therapeutic proteins to the next level
    • Büttel IC, Chamberlain P. Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals 2011;39:100-9.
    • (2011) Biologicals , vol.39 , pp. 100-109
    • Büttel, I.C.1    Chamberlain, P.2
  • 9
    • 77955636779 scopus 로고    scopus 로고
    • Biosimilars: Pharmacovigilance and risk management
    • Zuniga L, Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol Drug Saf 2010;19:661-9.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , pp. 661-669
    • Zuniga, L.1    Calvo, B.2
  • 10
    • 84884368579 scopus 로고    scopus 로고
    • Pro Pharma Communications International, GaBI Online-Generics and Biosimilars Initiative, GaBI Online, 18 March 2013, accessed 9 Apr 2013
    • Pro Pharma Communications International, GaBI Online-Generics and Biosimilars Initiative. Biosimilars-not-so-far-so-fast. GaBI Online. 18 March 2013. http://www.genengnews.com/insight-and-intelligence/biosimilars-not-so-far-so-fast/77899781/ (accessed 9 Apr 2013).
    • Biosimilars-not-so-far-so-fast
  • 11
    • 84885376216 scopus 로고    scopus 로고
    • Biosimilars in the European market
    • Rovira J, Lindner L, Gimenez E, et al. Biosimilars in the European market. GaBI J 2013;2:30-5.
    • (2013) GaBI J , vol.2 , pp. 30-35
    • Rovira, J.1    Lindner, L.2    Gimenez, E.3
  • 12
    • 84884385721 scopus 로고    scopus 로고
    • Guidance for industry on biosimilars
    • Food and Drug Administration, accessed 15 Aug 2013
    • Food and Drug Administration. Guidance for industry on biosimilars. Q & As regarding implementation of the BPCI Act of 2009: Questions and Answers Part I, Q.I.14. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm259809.htm (accessed 15 Aug 2013).
    • Q & As Regarding Implementation of the BPCI Act of 2009: Questions and Answers Part I, Q.I.14
  • 13
    • 84884408304 scopus 로고    scopus 로고
    • Pro Pharma Communications International, GaBI Online-Generics and Biosimilars Initiative, GaBI Online. 17 February 2012, accessed 18 Apr 2013
    • Pro Pharma Communications International, GaBI Online-Generics and Biosimilars Initiative. Interchangeability not covered in FDA draft biosimilar guidance. GaBI Online. 17 February 2012. http://www.gabionline.net/Guidelines/Interchangeability-not-covered-in-FDA-draft-biosimilar-guidance (accessed 18 Apr 2013).
    • Interchangeability Not Covered In FDA Draft Biosimilar Guidance
  • 14
    • 77956225724 scopus 로고    scopus 로고
    • European Medicines Agency, European Medicines Agency. 27 September 2012, accessed 27 Apr 2013
    • European Medicines Agency. Questions and answers on biosimilar medicines (similar biologic medicinal products). European Medicines Agency. 27 September 2012. http://www.emea.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf. (accessed 27 Apr 2013).
    • Questions and Answers On Biosimilar Medicines (similar Biologic Medicinal Products)
  • 15
    • 67549097000 scopus 로고    scopus 로고
    • Regulatory aspects of biosimilars in Europe
    • Zuñiga L, Calvo B. Regulatory aspects of biosimilars in Europe. Trends Biotechnol 2009;27:385-7.
    • (2009) Trends Biotechnol , vol.27 , pp. 385-387
    • Zuñiga, L.1    Calvo, B.2
  • 16
    • 84884394697 scopus 로고    scopus 로고
    • Pharma and Healthcare Insight, 25 September 2009, accessed 18 Apr 2013
    • Pharma and Healthcare Insight. Dutch health insurers to reimburse biosimilars. 25 September 2009. http://www.pharmaceuticalsinsight.com/file/81624/dutch-health-insurers-to-reimburse-biosimilars.html (accessed 18 Apr 2013).
    • Dutch Health Insurers to Reimburse Biosimilars
  • 17
    • 0030938041 scopus 로고    scopus 로고
    • The System of Objectified Judgement Analysis. A tool in rational drug selection for formulary purposes
    • Janknegt R, Steenhoek A. The System of Objectified Judgement Analysis. A tool in rational drug selection for formulary purposes. Drugs 1997;53:550-62.
    • (1997) Drugs , vol.53 , pp. 550-562
    • Janknegt, R.1    Steenhoek, A.2
  • 18
    • 35448970635 scopus 로고    scopus 로고
    • InforMatrix as an alternative tool in rational and transparent drug-decision making
    • Brenninkmeijer R, Mairs J, Timoney M, et al. InforMatrix as an alternative tool in rational and transparent drug-decision making. Expert Opin Pharmacother 2007;8 (Suppl 1):S31-6.
    • (2007) Expert Opin Pharmacother , vol.8 , Issue.SUPPL. 1
    • Brenninkmeijer, R.1    Mairs, J.2    Timoney, M.3
  • 19
    • 35448955324 scopus 로고    scopus 로고
    • Safe Therapeutic Economic Pharmaceutical Selection (STEPS): Development, introduction and use in Northern Ireland
    • Scott M, Timoney M, Mairs J, et al. Safe Therapeutic Economic Pharmaceutical Selection (STEPS): development, introduction and use in Northern Ireland. Expert Opin Pharmacother 2007;8(Suppl 1):S57-63.
    • (2007) Expert Opin Pharmacother , vol.8 , Issue.SUPPL. 1
    • Scott, M.1    Timoney, M.2    Mairs, J.3
  • 20
    • 84884380868 scopus 로고    scopus 로고
    • European Medicines Agency, European Medicines Agency. 21 January 2011, accessed 17 Apr 2013
    • European Medicines Agency. Pharmaceutical Quality System (ICHQ10). European Medicines Agency. 21 January 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf (accessed 17 Apr 2013).
    • Pharmaceutical Quality System (ICHQ10)
  • 21
    • 84884370620 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Food and Drug Administration. 10 November 2009, accessed 17 Apr 2013
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidance for industry Q8 (R2) Pharmaceutical development. Food and Drug Administration. 10 November 2009. http://www.fda.gov/downloads/Drugs/Guidances/ucm073507.pdf (accessed 17 Apr 2013).
    • Guidance For Industry Q8 (R2) Pharmaceutical Development
  • 22
    • 84884372553 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Food and Drug Administration. June, accessed 17 Apr 2013
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidance for industry Q9 Quality risk management. Food and Drug Administration. June 2006. http://www.fda.gov/downloads/Drugs/Guidances/ucm073511.pdf (accessed 17 Apr 2013).
    • (2006) Guidance For Industry Q9 Quality Risk Management
  • 23
    • 84884362499 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Food and Drug Administration. April, accessed 17 Apr 2013
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidance for industry Q10 Pharmaceutical quality system. Food and Drug Administration. April 2009. http://www.fda.gov/downloads/Drugs/Guidances/ucm073517.pdf (accessed 17 Apr 2013).
    • (2009) Guidance For Industry Q10 Pharmaceutical Quality System
  • 24
    • 84884384552 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Food and Drug Administration. November, accessed 17 Apr 2013
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidance for industry Q11 Development and manufacture of drug substances. Food and Drug Administration. November 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf (accessed 17 Apr 2013).
    • Guidance For Industry Q11 Development and Manufacture of Drug Substances
  • 26
    • 84873408792 scopus 로고    scopus 로고
    • European Parliament, European Commission. 8 June 2011, accessed 17 Apr 2013
    • European Parliament. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011. European Commission. 8 June 2011. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf (accessed 17 Apr 2013).
    • Directive 2011/62/EU of the European Parliament and of the Council Of 8 June 2011
  • 29
    • 84884364743 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 10 November 2000, accessed 17 Apr 2013
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Good manufacturing practice guide for active pharmaceutical ingredients Q7. 10 November 2000. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf (accessed 17 Apr 2013).
    • Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7
  • 31
    • 84856728382 scopus 로고    scopus 로고
    • European Medicines Agency, 23 April 2008, accessed 25 Apr 2013
    • European Medicines Agency. Omnitrope EPAR-scientific discussion. 23 April 2008. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Scientific_Discussion/human/000607/WC500043692.pdf (accessed 25 Apr 2013).
    • Omnitrope EPAR-scientific Discussion
  • 32
    • 84884371980 scopus 로고    scopus 로고
    • European Medicines Agency, 29 September 2009, accessed 25 Apr 2013
    • European Medicines Agency. Ratio orgrastim EPAR-scientific discussion. 29 September 2009. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Public_assessment_report/human/000825/WC500047793.pdf (accessed 25 Apr 2013).
    • Ratio Orgrastim EPAR-scientific Discussion
  • 33
    • 84884389615 scopus 로고    scopus 로고
    • European Medicines Agency, European Medicines Agency, 18 January 2007, accessed 17 Apr 2013
    • European Medicines Agency. EMEA/INS/GMP/23020/2007, An analysis of quality product defects in the centralised procedure. European Medicines Agency. 18 January 2007. http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004420.pdf (accessed 17 Apr 2013).
    • EMEA/INS/GMP/23020/2007, An Analysis of Quality Product Defects In the Centralised Procedure
  • 34
    • 19044397056 scopus 로고    scopus 로고
    • Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: Solving the mystery
    • Boven K, Knight J, Bader F, et al. Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. Nephrol Dial Transplant 2005;20(Suppl 3):33-40.
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 3 , pp. 33-40
    • Boven, K.1    Knight, J.2    Bader, F.3
  • 35
    • 84884388574 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 18 November 2004, accessed 20 Apr 2013
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Comparability of biotechnological/biological products subject to changes in their manufacturing process. 18 November 2004. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf (accessed 20 Apr 2013).
    • Comparability of Biotechnological/biological Products Subject to Changes In their Manufacturing Process
  • 36
    • 79953861167 scopus 로고    scopus 로고
    • Acceptable changes in quality attributes of glycosylated biopharmaceuticals
    • Schiestl M, Stangler T. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310-12.
    • (2011) Nat Biotechnol , vol.29 , pp. 310-312
    • Schiestl, M.1    Stangler, T.2
  • 37
    • 84885375616 scopus 로고    scopus 로고
    • European Medicines Agency, > 'Find Medicine' > [name] > 'Assessment history' > [name]: EPAR - Procedural steps taken and scientific information after authorisation; for products licensed before the deadline also refer to '[name]: EPAR -Steps taken after authorisation when a cutoff date has been used', accessed 20 Apr 2013
    • European Medicines Agency. Procedural steps taken and scientific information after authorization/Steps taken after authorisation when a cutoff date has been used. http://www.ema.europa.eu > 'Find Medicine' > [name] > 'Assessment history' > [name]: EPAR - Procedural steps taken and scientific information after authorisation; for products licensed before the deadline also refer to '[name]: EPAR -Steps taken after authorisation when a cutoff date has been used' (accessed 20 Apr 2013).
    • Procedural Steps Taken and Scientific Information After Authorization/Steps Taken After Authorisation When a Cutoff Date Has Been Used
  • 38
    • 84884410006 scopus 로고    scopus 로고
    • European Medicines Agency, 6 February 2009, accessed 27 Apr 2013
    • European Medicines Agency. Filgrastim-Hexal EPAR-Public assessment report. 6 February 2009. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Public_assessment_report/human/000918/WC500022471.pdf (accessed 27 Apr 2013).
    • Filgrastim-Hexal EPAR-Public Assessment Report
  • 39
    • 84945262700 scopus 로고    scopus 로고
    • European Medicines Agency, 8 June 2010, accessed 27 Apr 2013
    • European Medicines Agency. Nivestim EPAR-public assessment report. 8 June 2010. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Public_assessment_report/human/001142/WC500093664.pdf (accessed 27 Apr 2013).
    • Nivestim EPAR-public Assessment Report
  • 40
    • 84884401047 scopus 로고    scopus 로고
    • European Medicines Agency, 21 July 2011, accessed 17 Apr 2013
    • European Medicines Agency. EMEA/CHMP/EWP/192217/2009, Guideline on bioanalytical method validation. 21 July 2011. http://www.ema.europa.eu/docs/en_ GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf (accessed 17 Apr 2013).
    • EMEA/CHMP/EWP/192217/2009, Guideline On Bioanalytical Method Validation
  • 41
    • 84875432989 scopus 로고    scopus 로고
    • European Generic Medicines Association, Brussels: Sage
    • European Generic Medicines Association. Biosimilars handbook second edition. Brussels: Sage, 2011:29.
    • (2011) Biosimilars Handbook Second Edition , pp. 29
  • 44
    • 80052262016 scopus 로고    scopus 로고
    • Effects of surfaces and leachables on the stability of biopharmaceuticals
    • Published Online First: 26 April 2011 doi:10.1002/jps.22597
    • Bee JS, Randolph TW, Carpenter JF, et al. Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharm Sci 2011 Published Online First: 26 April 2011 doi:10.1002/jps.22597.
    • (2011) J Pharm Sci
    • Bee, J.S.1    Randolph, T.W.2    Carpenter, J.F.3
  • 45
    • 84883266005 scopus 로고    scopus 로고
    • World Health Organization, World Health Organization, accessed 3 Jul 2013
    • World Health Organization. Annex 5 Guidelines on good distribution practices for pharmaceutical products. World Health Organization. 2010. http://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodDistribution PracticesTRS957Annex5.pdf (accessed 3 Jul 2013).
    • (2010) Annex 5 Guidelines On Good Distribution Practices For Pharmaceutical Products
  • 47
    • 84873679430 scopus 로고    scopus 로고
    • Biosimilars in rheumatology: The wind of change
    • Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013;72:315-18.
    • (2013) Ann Rheum Dis , vol.72 , pp. 315-318
    • Schneider, C.K.1
  • 48
    • 33947710801 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins. Part 1
    • Sharma B. Immunogenicity of therapeutic proteins. Part 1: Impact of product handling. Biotech Adv 2007;25:310-17.
    • (2007) Impact of Product Handling. Biotech Adv , vol.25 , pp. 310-317
    • Sharma, B.1
  • 49
    • 33947661498 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins. Part: 2: Impact of container closure
    • Sharma B. Immunogenicity of therapeutic proteins. Part: 2: Impact of container closure. Biotech Adv 2007;25:318-24.
    • (2007) Biotech Adv , vol.25 , pp. 318-324
    • Sharma, B.1
  • 50
    • 79953681018 scopus 로고    scopus 로고
    • Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters
    • Barbosa M. Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters. Drug Discov Today 2011;16:345-53.
    • (2011) Drug Discov Today , vol.16 , pp. 345-353
    • Barbosa, M.1
  • 52
    • 84884367251 scopus 로고    scopus 로고
    • European Parliament. laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. European Medicines Agency. 30 April 2004
    • European Parliament. Regulation EC 726/2004 of the European Parliament and of the Council of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. European Medicines Agency. 30 April 2004. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF (accessed 27 Apr 2013).
    • Regulation EC 726/2004 of the European Parliament and of the Council of 31 March 2004
  • 54
    • 0003510680 scopus 로고
    • accessed 27 Apr 2013
    • European Commission. 1995. http://ec.europa.eu/health/files/eudralex/vol-1/reg_1995_540/reg_1995_540_en.pdf (accessed 27 Apr 2013).
    • (1995) European Commission
  • 55
    • 84884381282 scopus 로고    scopus 로고
    • European Parliament, Volume 9A of the Rules Governing Medicinal Products in the European Union, European Commission, September 2008, accessed 27 Apr 2013
    • European Parliament. Volume 9A of the Rules Governing Medicinal Products in the European Union. Guidelines on pharmacovigilance for medicinal products for human use. European Commission. September 2008. http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf (accessed 27 Apr 2013).
    • Guidelines On Pharmacovigilance For Medicinal Products For Human Use


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