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Volumn 161, Issue , 2008, Pages 261-270

Is the advent of biosimilars affecting the practice of nephrology and the safety of patients?

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; GENERIC DRUG; RECOMBINANT ERYTHROPOIETIN;

EID: 48049098835     PISSN: 03025144     EISSN: None     Source Type: Book Series    
DOI: 10.1159/000130700     Document Type: Conference Paper
Times cited : (6)

References (18)
  • 1
    • 33748692339 scopus 로고    scopus 로고
    • Pharmaceutical evaluation of biosimilars: Important differences from generic low-molecular-weight pharmaceuticals
    • Crommelin D, Bermejo T, Bissig M, et al: Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals. Eur J Hosp Pharmacy 2005;11:11-17.
    • (2005) Eur J Hosp Pharmacy , vol.11 , pp. 11-17
    • Crommelin, D.1    Bermejo, T.2    Bissig, M.3
  • 2
    • 0036598634 scopus 로고    scopus 로고
    • Bioequivalence and the immunogenicity of biopharmaceuticals
    • Schellekens H: Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002;1:457-462.
    • (2002) Nat Rev Drug Discov , vol.1 , pp. 457-462
    • Schellekens, H.1
  • 4
    • 37249016049 scopus 로고    scopus 로고
    • Differences between biopharmaceuticals and low-molecular-weight pharmaceuticals
    • Crommelin DJA: Differences between biopharmaceuticals and low-molecular-weight pharmaceuticals. Eur J Hosp Pharmacy 2003;8:74-76.
    • (2003) Eur J Hosp Pharmacy , vol.8 , pp. 74-76
    • Crommelin, D.J.A.1
  • 5
    • 0027998387 scopus 로고
    • On the immunogenicity of recombinant staphylokinase in patients and in animal models
    • Vanderschueren SM, Stassen JM, Collen D: On the immunogenicity of recombinant staphylokinase in patients and in animal models. Thromb Haemost 1994;72:297-301.
    • (1994) Thromb Haemost , vol.72 , pp. 297-301
    • Vanderschueren, S.M.1    Stassen, J.M.2    Collen, D.3
  • 6
    • 0034812115 scopus 로고    scopus 로고
    • Interferon alfacon-1: A review of its pharmacology and therapeutic efficacy in the treatment of chronic hepatitis C
    • Melian EB, Plosker GL: Interferon alfacon-1: a review of its pharmacology and therapeutic efficacy in the treatment of chronic hepatitis C. Drugs 2001;61:1661-1691.
    • (2001) Drugs , vol.61 , pp. 1661-1691
    • Melian, E.B.1    Plosker, G.L.2
  • 7
    • 0025020049 scopus 로고
    • Development of antibodies to unprotected glycosylation sites on recombinant human GM-CSF
    • Gribben JG, Devereux S, Thomas NSB, et al: Development of antibodies to unprotected glycosylation sites on recombinant human GM-CSF. Lancet 1990;335:434-437.
    • (1990) Lancet , vol.335 , pp. 434-437
    • Gribben, J.G.1    Devereux, S.2    Thomas, N.S.B.3
  • 8
    • 0031766727 scopus 로고    scopus 로고
    • The structure of human interferon-β: Implications for activity
    • Karpusas M, Whitty A, Runkel L, et al: The structure of human interferon-β: implications for activity. Cell Mol Life Sci 1998;54:1203-1216.
    • (1998) Cell Mol Life Sci , vol.54 , pp. 1203-1216
    • Karpusas, M.1    Whitty, A.2    Runkel, L.3
  • 9
    • 0027394923 scopus 로고
    • A sudden increase in factor VIII inhibitor development in multitransfused hemophilia patients in The Netherlands
    • Rosendaal FR, Nieuwenhuis HK, van den Berg HM, et al: A sudden increase in factor VIII inhibitor development in multitransfused hemophilia patients in The Netherlands. Blood 1993;81:2180-2186.
    • (1993) Blood , vol.81 , pp. 2180-2186
    • Rosendaal, F.R.1    Nieuwenhuis, H.K.2    van den Berg, H.M.3
  • 10
    • 0030754581 scopus 로고    scopus 로고
    • Clinical investigation of the immunogenicity of interferon-α2a
    • Ryff JC: Clinical investigation of the immunogenicity of interferon-α2a. J Interferon Cytokine Res 1997;17(suppl 1):S29-S33.
    • (1997) J Interferon Cytokine Res , vol.17 , Issue.SUPPL. 1
    • Ryff, J.C.1
  • 12
    • 21444445867 scopus 로고    scopus 로고
    • Activity evaluation and characterization of recombinant human erythropoietin in pharmaceutical products
    • Schmidt CA, Ramos AS, da Silva JEP, et al: Activity evaluation and characterization of recombinant human erythropoietin in pharmaceutical products. Arq Bras Endocrinol Metabol 2003;47:183-189.
    • (2003) Arq Bras Endocrinol Metabol , vol.47 , pp. 183-189
    • Schmidt, C.A.1    Ramos, A.S.2    da Silva, J.E.P.3
  • 13
    • 23244463549 scopus 로고    scopus 로고
    • Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: A parallel, randomized, double-blind study
    • Pérez-Oliva J, Casanova-González M, García- García I, et al: Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: a parallel, randomized, double-blind study. BMC Nephrol 2005;6:5-15.
    • (2005) BMC Nephrol , vol.6 , pp. 5-15
    • Pérez-Oliva, J.1    Casanova-González, M.2    García- García, I.3
  • 14
    • 21444442363 scopus 로고    scopus 로고
    • Biosimilar epoetins: An analysis based on recently implemented European Medicines Evaluation Agency guidelines on comparability of biopharmaceutical proteins
    • Combe C, Tredree R, Schellekens H: Biosimilar epoetins: an analysis based on recently implemented European Medicines Evaluation Agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy 2005;25:954-962.
    • (2005) Pharmacotherapy , vol.25 , pp. 954-962
    • Combe, C.1    Tredree, R.2    Schellekens, H.3
  • 15
    • 33644952525 scopus 로고    scopus 로고
    • EMEA Committee for Medicinal Products for Human Use:, CHMP/437/04, 30 October 2005
    • EMEA Committee for Medicinal Products for Human Use: Guideline on similar biological medicinal products. CHMP/437/04, 30 October 2005. http://www.emea.eu.int/pdfs/human/biosimilar/043704en.pdf
    • Guideline on similar biological medicinal products


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.