메뉴 건너뛰기




Volumn 10, Issue 3, 2007, Pages 405-410

Biosimilars: Opportunity or cause for concern?

Author keywords

[No Author keywords available]

Indexed keywords

ALPHEON; ANTIBODY; CYTOKINE; ERYTHROPOIETIN ANTIBODY; GENERIC DRUG; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; HORMONE; HUMAN GROWTH HORMONE; HUMAN INSULIN; INSULIN; INTERFERON; MEGAKARYOCYTE GROWTH AND DEVELOPMENT FACTOR; PROTEIN ANTIBODY; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT DNA; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; VACCINE; BIOLOGICAL PRODUCT;

EID: 34848844984     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (52)

References (35)
  • 1
    • 35948999359 scopus 로고    scopus 로고
    • Committee for medicinal products for human use. Guideline on Similar Biological Medicinal Products. CHMP/437/04 2005. 2005.
    • Committee for medicinal products for human use. Guideline on Similar Biological Medicinal Products. CHMP/437/04 2005. 2005.
  • 2
    • 33644862556 scopus 로고    scopus 로고
    • Point: Why biogenerics make sense
    • C. S. Ben Maimon. Point: why biogenerics make sense. Nat Biotechnol, 24:268-269, 2006.
    • (2006) Nat Biotechnol , vol.24 , pp. 268-269
    • Ben Maimon, C.S.1
  • 4
    • 33748687181 scopus 로고    scopus 로고
    • The protein science of biosimilars
    • M. Kuhlmann and A. Covic. The protein science of biosimilars. Nephrol Dial Transplant, 21 Suppl 5:v4-v8, 2006.
    • (2006) Nephrol Dial Transplant , vol.21 , Issue.SUPPL. 5
    • Kuhlmann, M.1    Covic, A.2
  • 5
    • 19044395847 scopus 로고    scopus 로고
    • H. Schellekens. Follow-on biologics: challenges of the next generation. Nephrol Dial Transplant, 20 Suppl 4:iv31-iv36, 2005.
    • H. Schellekens. Follow-on biologics: challenges of the "next generation". Nephrol Dial Transplant, 20 Suppl 4:iv31-iv36, 2005.
  • 6
    • 8344222959 scopus 로고    scopus 로고
    • How similar do 'biosimilars' need to be?
    • H. Schellekens. How similar do 'biosimilars' need to be? Nat Biotechnol, 22:1357-1359, 2004.
    • (2004) Nat Biotechnol , vol.22 , pp. 1357-1359
    • Schellekens, H.1
  • 7
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing biological products and assessing comparability following manufacturing changes
    • A. J. Chirino and A. Mire-Sluis. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol, 22:13 83-1391, 2004.
    • (2004) Nat Biotechnol , vol.22 , Issue.13 , pp. 83-1391
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 9
    • 0036598634 scopus 로고    scopus 로고
    • Bioequivalence and the immunogenicity of biopharmaceuticals
    • H. Schellekens. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov, 1:457-462, 2002.
    • (2002) Nat Rev Drug Discov , vol.1 , pp. 457-462
    • Schellekens, H.1
  • 10
    • 33644514001 scopus 로고    scopus 로고
    • Changes in biological source material
    • J. S. Robertson. Changes in biological source material. Biologicals, 34:61-63, 2006.
    • (2006) Biologicals , vol.34 , pp. 61-63
    • Robertson, J.S.1
  • 11
    • 33746169811 scopus 로고    scopus 로고
    • Biosimilars: How similar or dissimilar are they?
    • S. D. Roger. Biosimilars: how similar or dissimilar are they? Nephrology 11:341-346, 2006.
    • (2006) Nephrology , vol.11 , pp. 341-346
    • Roger, S.D.1
  • 12
    • 0036861899 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins: Clinical implications and future prospects
    • H. Schellekens. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther, 24:1720-1740, 2002.
    • (2002) Clin Ther , vol.24 , pp. 1720-1740
    • Schellekens, H.1
  • 13
    • 10644268697 scopus 로고    scopus 로고
    • Biosimilar therapeutic agents: Issues with bioequivalence and immunogenicity
    • H. Schellekens. Biosimilar therapeutic agents: issues with bioequivalence and immunogenicity. Eur J Clin Invest, 34:797-799, 2004.
    • (2004) Eur J Clin Invest , vol.34 , pp. 797-799
    • Schellekens, H.1
  • 14
    • 33748685217 scopus 로고    scopus 로고
    • Comparative testing and pharmacovigilance of biosimilars
    • F. Locatelli and S. Roger. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant, 21 Suppl. 5:v13-v16, 2006.
    • (2006) Nephrol Dial Transplant , vol.21 , Issue.SUPPL. 5
    • Locatelli, F.1    Roger, S.2
  • 16
    • 3242892400 scopus 로고    scopus 로고
    • Immunogenicity of recombinant human proteins: Causes and consequences
    • H. Schellekens and N. Casadevall. Immunogenicity of recombinant human proteins: causes and consequences. J Neurol, 251 Suppl 2:II4-II9, 2004.
    • (2004) J Neurol , vol.251 , Issue.SUPPL. 2
    • Schellekens, H.1    Casadevall, N.2
  • 17
    • 0842304936 scopus 로고    scopus 로고
    • Minimizing the immunogenicity of protein therapeutics
    • A. J. Chirino, M. L. Ary, and S. A. Marshall. Minimizing the immunogenicity of protein therapeutics. Drug Discov Today, 9:82-90, 2004.
    • (2004) Drug Discov Today , vol.9 , pp. 82-90
    • Chirino, A.J.1    Ary, M.L.2    Marshall, S.A.3
  • 18
    • 23644433705 scopus 로고    scopus 로고
    • H. P. Hartung, F. Munschauer, III, and H. Schellekens. Significance of neutralizing antibodies to interferon beta during treatment of multiple sclerosis: expert opinions based on the Proceedings of an International Consensus Conference. Eur J Neurol, 12:588-601, 2005.
    • H. P. Hartung, F. Munschauer, III, and H. Schellekens. Significance of neutralizing antibodies to interferon beta during treatment of multiple sclerosis: expert opinions based on the Proceedings of an International Consensus Conference. Eur J Neurol, 12:588-601, 2005.
  • 19
    • 30644457182 scopus 로고    scopus 로고
    • Fate of multiple sclerosis patients positive for neutralising antibodies towards interferon beta shifted to alternative treatments
    • S. Malucchi, M. Capobianco, F. Gilli, F. Marnetto, M. Caldano, A. Sala, and A. Bertolotto. Fate of multiple sclerosis patients positive for neutralising antibodies towards interferon beta shifted to alternative treatments. Neurol Sci, 26 Suppl 4:S213-S214, 2005.
    • (2005) Neurol Sci , vol.26 , Issue.SUPPL. 4
    • Malucchi, S.1    Capobianco, M.2    Gilli, F.3    Marnetto, F.4    Caldano, M.5    Sala, A.6    Bertolotto, A.7
  • 20
    • 3242880075 scopus 로고    scopus 로고
    • Measurement of neutralizing antibodies to interferon beta in patients with multiple sclerosis
    • F. Deisenhammer, H. Schellekens, and A. Bertolotto. Measurement of neutralizing antibodies to interferon beta in patients with multiple sclerosis. J Neurol, 251 Suppl 2:II31-II39, 2004.
    • (2004) J Neurol , vol.251 , Issue.SUPPL. 2
    • Deisenhammer, F.1    Schellekens, H.2    Bertolotto, A.3
  • 21
    • 0036658131 scopus 로고    scopus 로고
    • Thrombopoietin as a drug: Biologic expectations, clinical realities, and future directions
    • I. C. Haznedaroglu, H. Goker, M. Turgut, Y. Buyukasik, and M. Benekli. Thrombopoietin as a drug: biologic expectations, clinical realities, and future directions. Clin Appl Thromb Hemost, 8:193-212, 2002.
    • (2002) Clin Appl Thromb Hemost , vol.8 , pp. 193-212
    • Haznedaroglu, I.C.1    Goker, H.2    Turgut, M.3    Buyukasik, Y.4    Benekli, M.5
  • 22
    • 0035760892 scopus 로고    scopus 로고
    • Thrombocytopenia caused by the development of antibodies to thrombopoietin
    • J. Li, C. Yang, Y. Xia, A. Bertino, J. Glaspy, M. Roberts, and D. J. Kuter. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood, 98:3241-3248, 2001.
    • (2001) Blood , vol.98 , pp. 3241-3248
    • Li, J.1    Yang, C.2    Xia, Y.3    Bertino, A.4    Glaspy, J.5    Roberts, M.6    Kuter, D.J.7
  • 23
    • 15844367464 scopus 로고    scopus 로고
    • Immunologic mechanisms of EPO-associated pure red cell aplasia
    • H. Schellekens. Immunologic mechanisms of EPO-associated pure red cell aplasia. Best Pract Res Clin Haematol, 18:473-480, 2005.
    • (2005) Best Pract Res Clin Haematol , vol.18 , pp. 473-480
    • Schellekens, H.1
  • 24
    • 0036319285 scopus 로고    scopus 로고
    • Antibodies against rHuEPO: Native and recombinant
    • N. Casadevall. Antibodies against rHuEPO: native and recombinant. Nephrol Dial Transplant, 17 Suppl 5:42-47, 2002.
    • (2002) Nephrol Dial Transplant , vol.17 , Issue.SUPPL. 5 , pp. 42-47
    • Casadevall, N.1
  • 26
    • 0344668586 scopus 로고    scopus 로고
    • N. Casadevall. Pure red cell aplasia and antierythropoietin antibodies in patients treated with epoetin. Nephrol Dial Transplant, 18 Suppl 8:viii37-viii41,2003.
    • N. Casadevall. Pure red cell aplasia and antierythropoietin antibodies in patients treated with epoetin. Nephrol Dial Transplant, 18 Suppl 8:viii37-viii41,2003.
  • 27
    • 4544293857 scopus 로고    scopus 로고
    • Erythropoietic proteins and antibody-mediated pure red cell aplasia: A potential role for micelles
    • H. Schellekens. Erythropoietic proteins and antibody-mediated pure red cell aplasia: a potential role for micelles. Nephrol Dial Transplant, 19:2422, 2004.
    • (2004) Nephrol Dial Transplant , vol.19 , pp. 2422
    • Schellekens, H.1
  • 28
    • 19044397056 scopus 로고    scopus 로고
    • K. Boven, J. Knight, F. Bader, J. Rossert, K. U. Eckardt, and N. Casadevall. Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. Nephrol Dial Transplant, 20 Suppl 3:iii33-iii40, 2005.
    • K. Boven, J. Knight, F. Bader, J. Rossert, K. U. Eckardt, and N. Casadevall. Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mystery. Nephrol Dial Transplant, 20 Suppl 3:iii33-iii40, 2005.
  • 30
    • 23744481594 scopus 로고    scopus 로고
    • Antibodies against erythropoietin and other protein-based therapeutics: An overview
    • A. Kromminga and H. Schellekens. Antibodies against erythropoietin and other protein-based therapeutics: an overview. Ann N Y Acad Sci, 1050:257-265, 2005.
    • (2005) Ann N Y Acad Sci , vol.1050 , pp. 257-265
    • Kromminga, A.1    Schellekens, H.2
  • 31
    • 33745096842 scopus 로고    scopus 로고
    • Eprex-associated pure red cell aplasia and leachates
    • H. Schellekens and W. Jiskoot. Eprex-associated pure red cell aplasia and leachates. Nat Biotechnol, 24:613-614, 2006.
    • (2006) Nat Biotechnol , vol.24 , pp. 613-614
    • Schellekens, H.1    Jiskoot, W.2
  • 32
    • 33748707376 scopus 로고    scopus 로고
    • European regulatory guidelines for biosimilars
    • A. Wiecek and A. Mikhail. European regulatory guidelines for biosimilars. Nephrol Dial Transplant, 21 Suppl 5:v17-v20, 2006.
    • (2006) Nephrol Dial Transplant , vol.21 , Issue.SUPPL. 5
    • Wiecek, A.1    Mikhail, A.2
  • 33
    • 0142124925 scopus 로고    scopus 로고
    • The safety of biologic agents in early rheumatoid arthritis
    • A. Kavanaugh and E. C. Keystone. The safety of biologic agents in early rheumatoid arthritis. Clin Exp Rheumatol, 21:S203-S208, 2003.
    • (2003) Clin Exp Rheumatol , vol.21
    • Kavanaugh, A.1    Keystone, E.C.2
  • 35
    • 35948993098 scopus 로고    scopus 로고
    • Committee for medicinal products for human use. Annex guideline on similar biological medicinal products containing biotechnology-Derived proteins as active substance: Non-clinical and clinical issues: Guidance on biosimilar medicinal products containing recombinant erythropoietins. European Medicines Agency. EMEA/CHMP/94526/2005 2005. 2005.
    • Committee for medicinal products for human use. Annex guideline on similar biological medicinal products containing biotechnology-Derived proteins as active substance: Non-clinical and clinical issues: Guidance on biosimilar medicinal products containing recombinant erythropoietins. European Medicines Agency. EMEA/CHMP/94526/2005 2005. 2005.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.