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Volumn 31, Issue 2, 2017, Pages 83-91

Interchangeability of Biosimilars: A European Perspective

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ANTIANEMIC AGENT; BIOSIMILAR AGENT; ETANERCEPT; FILGRASTIM; HUMAN GROWTH HORMONE; INFLIXIMAB; INFLIXIMAB DYYB; INSULIN GLARGINE; RECOMBINANT ERYTHROPOIETIN; CT-P13; MONOCLONAL ANTIBODY;

EID: 85010755037     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-017-0210-0     Document Type: Article
Times cited : (148)

References (66)
  • 1
    • 84884381595 scopus 로고    scopus 로고
    • Process on Corporate Responsibility in the Field of Pharmaceuticals Access to Medicines in Europe, A Consensus Information Document
    • European Commission, DG Enterprise and industry. What you Need to Know about Biosimilar Medicinal Products. Process on Corporate Responsibility in the Field of Pharmaceuticals Access to Medicines in Europe. A Consensus Information Document, 2013. http://europa.eu/geninfo/query/resultaction.jsp?query_source=GROWTH&QueryText=biosimilars&op=Search&swlang=en&form_build_id=form-CA4kk1hS9th2Qw_AyEvYWFKAUUlCNvY6kFflINvXlD4&form_id=nexteuropa_europa_search_search_form. Accessed 30 Sept 2016.
    • (2013) What you Need to Know about Biosimilar Medicinal Products
  • 2
    • 84899412968 scopus 로고    scopus 로고
    • Biosimilars in oncology: from development to clinical practice
    • PID: 24767633
    • Rak Tkaczuk K, Jacobs I. Biosimilars in oncology: from development to clinical practice. Semin Oncol. 2014;41(Suppl 3):S3–12.
    • (2014) Semin Oncol , vol.41 , pp. S3-S12
    • Rak Tkaczuk, K.1    Jacobs, I.2
  • 3
    • 84969996341 scopus 로고    scopus 로고
    • An insurmountable fifth hurdle?
    • Ebbers HC, Chamberlain P. Interchangeability. An insurmountable fifth hurdle? GaBI J 2014;3:88–93.
    • (2014) GaBI J , vol.3 , pp. 88-93
    • Ebbers, H.C.1    Interchangeability, C.P.2
  • 4
    • 84870933584 scopus 로고    scopus 로고
    • Interchangeability, immunogenicity and biosimilars
    • COI: 1:CAS:528:DC%2BC38Xhsl2ltbnO, PID: 23222784
    • Ebbers H, Crow S, Vulto A, Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol. 2012;30:1186–90.
    • (2012) Nat Biotechnol , vol.30 , pp. 1186-1190
    • Ebbers, H.1    Crow, S.2    Vulto, A.3    Schellekens, H.4
  • 5
    • 84900459730 scopus 로고    scopus 로고
    • Biosimilars in the therapy of inflammatory bowel diseases
    • COI: 1:CAS:528:DC%2BC2cXnsVSktrY%3D, PID: 24722561
    • Hlavaty T, Letkovsky J. Biosimilars in the therapy of inflammatory bowel diseases. Eur J Gastroenterol Hepatol. 2014;26:581–687.
    • (2014) Eur J Gastroenterol Hepatol , vol.26 , pp. 581-687
    • Hlavaty, T.1    Letkovsky, J.2
  • 6
    • 85017010592 scopus 로고    scopus 로고
    • Interchangeability and Physician Notification. Accessed 30 Sept 2016
    • The Alliance for Safe Biologic Medicines (ASBM). Interchangeability and Physician Notification. http://safebiologics.org/resources/in-the-states/. Accessed 30 Sept 2016.
    • (2016) The Alliance for Safe Biologic Medicines (ASBM)
  • 7
    • 80051984166 scopus 로고    scopus 로고
    • Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations
    • COI: 1:CAS:528:DC%2BC3MXhsVKhu7zI, PID: 21861538
    • Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs. 2011;71:1527–36.
    • (2011) Drugs , vol.71 , pp. 1527-1536
    • Dranitsaris, G.1    Amir, E.2    Dorward, K.3
  • 8
    • 84868121869 scopus 로고    scopus 로고
    • Biologicals and biosimilars: a review of the science and its implications
    • Declerck P. Biologicals and biosimilars: a review of the science and its implications. GaBI J. 2012;1:13–6.
    • (2012) GaBI J. , vol.1 , pp. 13-16
    • Declerck, P.1
  • 9
    • 84896549088 scopus 로고    scopus 로고
    • Expert perspectives on biosimilar monoclonal antibodies in breast cancer
    • COI: 1:CAS:528:DC%2BC2cXjtFSlu7s%3D, PID: 24562824
    • Cortes J, Curigliano G, Dieras V. Expert perspectives on biosimilar monoclonal antibodies in breast cancer. Breast Cancer Res Treat. 2014;144:233–9.
    • (2014) Breast Cancer Res Treat , vol.144 , pp. 233-239
    • Cortes, J.1    Curigliano, G.2    Dieras, V.3
  • 10
    • 84877300355 scopus 로고    scopus 로고
    • Building a wall against biosimilars
    • No authors listed. Building a wall against biosimilars. Nat Biotechnol. 2013;31:264.
    • (2013) Nat Biotechnol , vol.31 , pp. 264
  • 11
    • 84959042048 scopus 로고    scopus 로고
    • Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents
    • PID: 26808864
    • Vezér B, Buzás Z, Sebeszta M, Zrubka Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr Med Res Opin. 2016;32:829–34.
    • (2016) Curr Med Res Opin , vol.32 , pp. 829-834
    • Vezér, B.1    Buzás, Z.2    Sebeszta, M.3    Zrubka, Z.4
  • 12
    • 84982141850 scopus 로고    scopus 로고
    • ICH Q5E, CPMP/ICH/5721/03. Comparability of Biotechnological/Biological Products: Note for guidance on biotechnological/biological products subject to changes in their manufacturing process. Accessed 30 Sept 2016
    • European Medicines Agency (EMA). ICH Q5E, CPMP/ICH/5721/03. Comparability of Biotechnological/Biological Products: Note for guidance on biotechnological/biological products subject to changes in their manufacturing process. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000888.jsp&mid=WC0b01ac058002956b. Accessed 30 Sept 2016.
    • (2016) European Medicines Agency (EMA)
  • 13
    • 84982141850 scopus 로고    scopus 로고
    • Guideline on Similar Biological Medicinal Products. Accessed 30 Sept 2016.
    • European Medicines Agency (EMA): Guideline on Similar Biological Medicinal Products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 30 Sept 2016.
    • (2016) European Medicines Agency (EMA)
  • 14
    • 84867307195 scopus 로고    scopus 로고
    • The safety of switching between therapeutic proteins
    • COI: 1:CAS:528:DC%2BC38XhsV2ktb3L, PID: 22849511
    • Ebbers H, Münzenberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther. 2012;12:1473–85.
    • (2012) Expert Opin Biol Ther , vol.12 , pp. 1473-1485
    • Ebbers, H.1    Münzenberg, M.2    Schellekens, H.3
  • 15
    • 84926639724 scopus 로고    scopus 로고
    • The ESA scenario gets complex: from biosimilar epoetins to activin traps
    • PID: 24748667
    • Jelkmann W. The ESA scenario gets complex: from biosimilar epoetins to activin traps. Nephrol Dial Transplant. 2015;30:553–9.
    • (2015) Nephrol Dial Transplant , vol.30 , pp. 553-559
    • Jelkmann, W.1
  • 16
    • 79961203419 scopus 로고    scopus 로고
    • Biosimilars: why terminology matters
    • COI: 1:CAS:528:DC%2BC3MXpvVOls74%3D, PID: 21822237
    • Weise M, Bielsky MC, De Smet K, et al. Biosimilars: why terminology matters. Nat Biotechnol. 2011;29(8):690–3.
    • (2011) Nat Biotechnol , vol.29 , Issue.8 , pp. 690-693
    • Weise, M.1    Bielsky, M.C.2    De Smet, K.3
  • 17
    • 84982141850 scopus 로고    scopus 로고
    • European Public Assessment reports. Accessed 30 Sept 2016.
    • European Medicines Agency (EMA). European Public Assessment reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124. Accessed 30 Sept 2016.
    • (2016) European Medicines Agency (EMA)
  • 18
    • 84961880187 scopus 로고    scopus 로고
    • A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials
    • COI: 1:CAS:528:DC%2BC28XktFGltrY%3D, PID: 26574160
    • Yu Y, Teerenstra S, Neef C, Burger D, Maliepaard M. A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials. Br J Clin Pharmacol. 2016;81(4):667–78.
    • (2016) Br J Clin Pharmacol. , vol.81 , Issue.4 , pp. 667-678
    • Yu, Y.1    Teerenstra, S.2    Neef, C.3    Burger, D.4    Maliepaard, M.5
  • 19
    • 62949147825 scopus 로고    scopus 로고
    • Immunogenicity assessment of biotechnology-derived therapeutic proteins, rev1. Accessed 1 Sept 2019
    • European Medicines Agency (EMA). Immunogenicity assessment of biotechnology-derived therapeutic proteins, rev1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001391.jsp&mid=WC0b01ac058002958c. Accessed 1 Sept 2019.
    • European Medicines Agency (EMA)
  • 20
    • 0029162562 scopus 로고
    • Comprehensive pharmacokinetics of a humanized antibody and analysis of residual anti-idiotypic responses
    • COI: 1:CAS:528:DyaK2MXns1ylsrg%3D, PID: 7558164
    • Stephens S, Emtage S, Vetterlein O, Chaplin L, Bebbington C, Nesbitt A, et al. Comprehensive pharmacokinetics of a humanized antibody and analysis of residual anti-idiotypic responses. Immunology. 1995;85:668–74.
    • (1995) Immunology , vol.85 , pp. 668-674
    • Stephens, S.1    Emtage, S.2    Vetterlein, O.3    Chaplin, L.4    Bebbington, C.5    Nesbitt, A.6
  • 21
    • 85017008355 scopus 로고    scopus 로고
    • Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learned and open questions based on 10 years’ experience of the European Union regulatory pathway
    • Chamberlain P. Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learned and open questions based on 10 years’ experience of the European Union regulatory pathway. Biosimilars. 2014;4:23–43.
    • (2014) Biosimilars. , vol.4 , pp. 23-43
    • Chamberlain, P.1
  • 22
    • 40849142102 scopus 로고    scopus 로고
    • Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose
    • COI: 1:CAS:528:DC%2BD1cXjt1aitLk%3D, PID: 18337601
    • Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008;358:1109–17.
    • (2008) N Engl J Med , vol.358 , pp. 1109-1117
    • Chung, C.H.1    Mirakhur, B.2    Chan, E.3    Le, Q.T.4    Berlin, J.5    Morse, M.6
  • 23
    • 0037075272 scopus 로고    scopus 로고
    • Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
    • COI: 1:CAS:528:DC%2BD38XhtFCktr8%3D, PID: 11844847
    • Casadevall N, Nataf JM, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346:469–75.
    • (2002) N Engl J Med , vol.346 , pp. 469-475
    • Casadevall, N.1    Nataf, J.M.2    Viron, B.3
  • 25
    • 84973896889 scopus 로고    scopus 로고
    • Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima
    • PID: 25897019
    • Ben-Horin S, Yavzori M, Benhar I, Fudim E, Picard O, Ungar B, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2016;65(7):1132–8.
    • (2016) Gut , vol.65 , Issue.7 , pp. 1132-1138
    • Ben-Horin, S.1    Yavzori, M.2    Benhar, I.3    Fudim, E.4    Picard, O.5    Ungar, B.6
  • 26
    • 77649326083 scopus 로고    scopus 로고
    • Regulation and dysregulation of immunoglobulin E: a molecular and clinical perspective
    • PID: 20178634
    • Pate M, Kelly Smith J, Chi D, Krishnaswamy G. Regulation and dysregulation of immunoglobulin E: a molecular and clinical perspective. Clin Mol Allergy. 2010;8:3.
    • (2010) Clin Mol Allergy. , vol.8 , pp. 3
    • Pate, M.1    Kelly Smith, J.2    Chi, D.3    Krishnaswamy, G.4
  • 28
    • 0035139983 scopus 로고    scopus 로고
    • Danger signals: SOS to the immune system
    • COI: 1:CAS:528:DC%2BD3MXhtFChsLc%3D, PID: 11154927
    • Gallucci S, Matzinger P. Danger signals: SOS to the immune system. Curr Opin Immunol. 2001;13:114–9.
    • (2001) Curr Opin Immunol , vol.13 , pp. 114-119
    • Gallucci, S.1    Matzinger, P.2
  • 29
    • 84887987723 scopus 로고    scopus 로고
    • Adaptive immune activation: glycosylation does matter
    • COI: 1:CAS:528:DC%2BC3sXhslOlsL3E, PID: 24231619
    • Wolfert MA, Boons G-J. Adaptive immune activation: glycosylation does matter. Nat Chem Biol. 2013;9:776–84.
    • (2013) Nat Chem Biol , vol.9 , pp. 776-784
    • Wolfert, M.A.1    Boons, G.-J.2
  • 30
    • 84873679430 scopus 로고    scopus 로고
    • Biosimilars in rheumatology: the wind of change
    • COI: 1:CAS:528:DC%2BC3sXjvFOjtbs%3D, PID: 23390018
    • Schneider C. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;72:315–8.
    • (2013) Ann Rheum Dis , vol.72 , pp. 315-318
    • Schneider, C.1
  • 31
    • 70350776252 scopus 로고    scopus 로고
    • Therapeutic equivalence, long-term and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
    • COI: 1:CAS:528:DC%2BD1MXhs1WisrfL, PID: 19863881
    • Haag-Weber M, Vetter A, Thyroff-Friesinger U, INJ-study group. Therapeutic equivalence, long-term and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol. 2009;72:380–9.
    • (2009) Clin Nephrol , vol.72 , pp. 380-389
    • Haag-Weber, M.1    Vetter, A.2    Thyroff-Friesinger, U.3
  • 32
    • 84862644490 scopus 로고    scopus 로고
    • Tungsten-induced denaturation and aggregation of epoetin-alfa during primary packaging as a cause of immunogenicity
    • COI: 1:CAS:528:DC%2BC3MXhsVyktrfJ, PID: 22094831
    • Seidl A, Hainzl O, Richter M, Fischer R, Böhm S, Deutel B, et al. Tungsten-induced denaturation and aggregation of epoetin-alfa during primary packaging as a cause of immunogenicity. Pharm Res. 2012;29:1454–67.
    • (2012) Pharm Res , vol.29 , pp. 1454-1467
    • Seidl, A.1    Hainzl, O.2    Richter, M.3    Fischer, R.4    Böhm, S.5    Deutel, B.6
  • 33
    • 62549141493 scopus 로고    scopus 로고
    • Impact of illegal trade on the quality of epoetin alfa in Thailand
    • COI: 1:CAS:528:DC%2BD1MXkvVCqsrw%3D, PID: 19302906
    • Fotiou F, Aravind S, Wang PP, Nerapusee O. Impact of illegal trade on the quality of epoetin alfa in Thailand. Clin Ther. 2009;31:336–46.
    • (2009) Clin Ther , vol.31 , pp. 336-346
    • Fotiou, F.1    Aravind, S.2    Wang, P.P.3    Nerapusee, O.4
  • 34
  • 36
    • 72749127602 scopus 로고    scopus 로고
    • Influence of interferon-beta therapy switching on neutralizing antibody titres: results from the Austrian Switch Study
    • COI: 1:CAS:528:DC%2BC3cXhtlaqsrs%3D, PID: 19965519
    • Gneiss C, Koudouovoh-Tripp PM, Ropele S, Gotwald T, Ehling R, Lutterotti A, et al. Influence of interferon-beta therapy switching on neutralizing antibody titres: results from the Austrian Switch Study. Mult Scler. 2009;15:1481–8.
    • (2009) Mult Scler. , vol.15 , pp. 1481-1488
    • Gneiss, C.1    Koudouovoh-Tripp, P.M.2    Ropele, S.3    Gotwald, T.4    Ehling, R.5    Lutterotti, A.6
  • 37
    • 84982141850 scopus 로고    scopus 로고
    • CHMP assessment report: herceptin subcutaneous formulation. Accessed 30 Sept 2016
    • European Medicines Agency (EMA). CHMP assessment report: herceptin subcutaneous formulation. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000278/WC500153233.pdf. Accessed 30 Sept 2016.
    • (2016) European Medicines Agency (EMA)
  • 40
    • 85021225235 scopus 로고    scopus 로고
    • ® is safe and feasible: a prospective, open-label study.2016. doi: (Epub 22 September 2016).
    • ® is safe and feasible: a prospective, open-label study. J Crohns Colitis. 2016. doi:10.1093/ecco-jcc/jjw166 (Epub 22 September 2016).
    • (2016) J Crohns Colitis
  • 41
    • 84918518708 scopus 로고    scopus 로고
    • Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden
    • PID: 24392303
    • Flodmark C-E, Lilja K, Woehling H, Järvholm K. Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden. Biol Ther. 2013;3:35–43.
    • (2013) Biol Ther. , vol.3 , pp. 35-43
    • Flodmark, C.-E.1    Lilja, K.2    Woehling, H.3    Järvholm, K.4
  • 42
    • 84898803216 scopus 로고    scopus 로고
    • Effect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical data
    • Romer T, Zabransky M, Walczak M, Szalecki M, Balzer S. Effect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical data. Biol Ther. 2011;1:005.
    • (2011) Biol Ther. , vol.1 , pp. 005
    • Romer, T.1    Zabransky, M.2    Walczak, M.3    Szalecki, M.4    Balzer, S.5
  • 43
    • 84978817333 scopus 로고    scopus 로고
    • ® from other recombinant human growth hormone therapies: retrospective study in an integrated healthcare system
    • PID: 25096555
    • ® from other recombinant human growth hormone therapies: retrospective study in an integrated healthcare system. Biol Ther. 2014;4:27–39.
    • (2014) Biol Ther. , vol.4 , pp. 27-39
    • Rashid, N.1    Saenger, P.2    Wu, Y.L.3
  • 44
    • 84876736657 scopus 로고    scopus 로고
    • A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia
    • PID: 23052412
    • Hörbrand F, Bramlage P, Fischaleck J, Hasford J, Brunkhorst R. A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol. 2013;69:929–36.
    • (2013) Eur J Clin Pharmacol , vol.69 , pp. 929-936
    • Hörbrand, F.1    Bramlage, P.2    Fischaleck, J.3    Hasford, J.4    Brunkhorst, R.5
  • 45
    • 84966417145 scopus 로고    scopus 로고
    • Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
    • PID: 27130908
    • Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76(2):355–63. doi:10.1136/annrheumdis-2015-208786.
    • (2017) Ann Rheum Dis , vol.76 , Issue.2 , pp. 355-363
    • Yoo, D.H.1    Prodanovic, N.2    Jaworski, J.3    Miranda, P.4    Ramiterre, E.5    Lanzon, A.6
  • 46
    • 84901920947 scopus 로고    scopus 로고
    • A review of CT-P13: an infliximab biosimilar
    • COI: 1:CAS:528:DC%2BC2cXmt1GlsLY%3D, PID: 24723086
    • McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28:313–21.
    • (2014) BioDrugs. , vol.28 , pp. 313-321
    • McKeage, K.1
  • 47
    • 84946601256 scopus 로고    scopus 로고
    • Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data
    • COI: 1:CAS:528:DC%2BC2MXhvVSltL3N, PID: 26549204
    • Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, Sokka T. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15(12):1677–83.
    • (2015) Expert Opin Biol Ther. , vol.15 , Issue.12 , pp. 1677-1683
    • Nikiphorou, E.1    Kautiainen, H.2    Hannonen, P.3    Asikainen, J.4    Kokko, A.5    Rannio, T.6    Sokka, T.7
  • 48
    • 84995578185 scopus 로고    scopus 로고
    • The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis
    • COI: 1:CAS:528:DC%2BC28Xht1ygsr7O, PID: 27473452
    • Dapavo P, Vujic I, Fierro MT, Pietro Q, Sanlorenzo M. The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75(4):736–9. doi:10.1016/j.jaad.2016.04.068.
    • (2016) J Am Acad Dermatol , vol.75 , Issue.4 , pp. 736-739
    • Dapavo, P.1    Vujic, I.2    Fierro, M.T.3    Pietro, Q.4    Sanlorenzo, M.5
  • 49
    • 85011663828 scopus 로고    scopus 로고
    • Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations
    • COI: 1:STN:280:DC%2BC28rmtlOjtw%3D%3D, PID: 26721942
    • Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10(2):127–32.
    • (2016) J Crohns Colitis. , vol.10 , Issue.2 , pp. 127-132
    • Sieczkowska, J.1    Jarzebicka, D.2    Banaszkiewicz, A.3    Plocek, A.4    Gawronska, A.5    Toporowska-Kowalska, E.6
  • 50
    • 84942325078 scopus 로고    scopus 로고
    • Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea
    • PID: 26395533
    • Park SH, Kim YH, Lee JH, Kwon HJ, Lee SH, Park DI, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol. 2015;9(Suppl 1):35–44.
    • (2015) Expert Rev Gastroenterol Hepatol. , vol.9 , pp. 35-44
    • Park, S.H.1    Kim, Y.H.2    Lee, J.H.3    Kwon, H.J.4    Lee, S.H.5    Park, D.I.6
  • 53
    • 85017017931 scopus 로고    scopus 로고
    • Comparable safety and immunogenicity and sustained efficacy after transition To SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study (a poster
    • Smolen JS, Choe J-Y, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. (FRI0162) comparable safety and immunogenicity and sustained efficacy after transition To SB2 (an infliximab biosimilar) vs ongoing infliximab reference product in patients with rheumatoid arthritis: results of phase III transition study (a poster. Ann Rheum Dis. 2016;75:488.)
    • (2016) Ann Rheum Dis , vol.75 , pp. 488
    • Smolen, J.S.1    Choe, J.-Y.2    Prodanovic, N.3    Niebrzydowski, J.4    Staykov, I.5    Dokoupilova, E.6
  • 54
    • 85017000928 scopus 로고    scopus 로고
    • Meeting materials, arthritis advisory committee. Briefing Information for the July 12–13, 2016
    • US Department of Health and Human Services. US Food and Drug Administration. 2016 Meeting materials, arthritis advisory committee. Briefing Information for the July 12–13, 2016, Meeting of the Arthritis Advisory Committee (AAC). http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/ucm481975.htm. Accessed 30 Dec 2016.
    • (2016) Meeting of the Arthritis Advisory Committee (AAC
  • 55
    • 84977763676 scopus 로고    scopus 로고
    • Biosimilars: terms of use
    • COI: 1:CAS:528:DC%2BC2MXhslyksrnL, PID: 26397731
    • Declerck P, Mellstedt H, Danese S. Biosimilars: terms of use. Curr Med Res Opin. 2015;31:2325–30.
    • (2015) Curr Med Res Opin , vol.31 , pp. 2325-2330
    • Declerck, P.1    Mellstedt, H.2    Danese, S.3
  • 56
    • 84953403470 scopus 로고    scopus 로고
    • The constrained prescription interchangeability and substitution of biosimilars
    • COI: 1:CAS:528:DC%2BC2MXht1ensLfI, PID: 26154003
    • Minghetti P, Rocco P, Schellekens H. The constrained prescription interchangeability and substitution of biosimilars. Nat Biotechnol. 2015;33:688–9.
    • (2015) Nat Biotechnol , vol.33 , pp. 688-689
    • Minghetti, P.1    Rocco, P.2    Schellekens, H.3
  • 57
    • 84881122457 scopus 로고    scopus 로고
    • Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance data bases
    • PID: 23771794
    • Vermeer N, Straus S, Mantel-Teeuwisse A, Domergue F, Egberts ACG, Leufkens HGM, de Bruin ML. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance data bases. Drug Saf. 2013;36:617–25.
    • (2013) Drug Saf , vol.36 , pp. 617-625
    • Vermeer, N.1    Straus, S.2    Mantel-Teeuwisse, A.3    Domergue, F.4    Egberts, A.C.G.5    Leufkens, H.G.M.6    de Bruin, M.L.7
  • 58
    • 59349100314 scopus 로고    scopus 로고
    • Initiating insulin therapy with, or switching existing insulin therapy to, insulin aspart 30/70 (Novomix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study
    • COI: 1:CAS:528:DC%2BC3cXksVequ74%3D, PID: 19187170
    • Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al. Initiating insulin therapy with, or switching existing insulin therapy to, insulin aspart 30/70 (Novomix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract. 2009;63:522–31.
    • (2009) Int J Clin Pract , vol.63 , pp. 522-531
    • Valensi, P.1    Benroubi, M.2    Borzi, V.3    Gumprecht, J.4    Kawamori, R.5    Shaban, J.6
  • 59
    • 77957025432 scopus 로고    scopus 로고
    • Switching biologicals for psoriasis
    • PID: 20854399
    • Ormerod AD. Switching biologicals for psoriasis. Br J Dermatol. 2010;163:667–9.
    • (2010) Br J Dermatol , vol.163 , pp. 667-669
    • Ormerod, A.D.1
  • 60
    • 79751472562 scopus 로고    scopus 로고
    • The London position statement of the world congress of gastroenterology on biological therapy for IBD with the European Crohn’s and colitis organisation: when to start, when to stop, which drug to choose and how to predict response?
    • PID: 21045814
    • D’Haens GR, Panaccione R, Higgins PD, et al. The London position statement of the world congress of gastroenterology on biological therapy for IBD with the European Crohn’s and colitis organisation: when to start, when to stop, which drug to choose and how to predict response? Am J Gastroenterol. 2011;106:199–212.
    • (2011) Am J Gastroenterol , vol.106 , pp. 199-212
    • D’Haens, G.R.1    Panaccione, R.2    Higgins, P.D.3
  • 61
    • 84997639519 scopus 로고    scopus 로고
    • Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016
    • Annese V, Avendaño-Solá C, Breedveld F, Ekman N, Giezen TJ, Gomollón F, et al. Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016. GaBI J. 2016;5(2):74–83.
    • (2016) GaBI J. , vol.5 , Issue.2 , pp. 74-83
    • Annese, V.1    Avendaño-Solá, C.2    Breedveld, F.3    Ekman, N.4    Giezen, T.J.5    Gomollón, F.6
  • 62
    • 85021327117 scopus 로고    scopus 로고
    • Are biosimilar medicinal products interchangeable?. Accessed 19 Jan 2017
    • Medicines Evaluation Board (MEB). Are biosimilar medicinal products interchangeable? https://english.cbg-meb.nl/latest/news/2015/08/17/clarification-of-stance-on-biological-and-biosimilarmedicines. Accessed 19 Jan 2017.
    • (2017) Medicines Evaluation Board (MEB)
  • 63
    • 85016940380 scopus 로고    scopus 로고
    • Are biosimilars interchangeable?. Accessed 19 Jan 2017
    • Finnish Medicines Agency Fimea. Are biosimilars interchangeable? https://www.fimea.fi/documents/542809/838272/29197_Biosimilaarien_vaihtokelpoisuus_EN.pdf. Accessed 19 Jan 2017.
    • (2017) Finnish Medicines Agency Fimea
  • 64
    • 85016977720 scopus 로고    scopus 로고
    • Biosimilar medicines: a national prescribing framework
    • Healthcare Improvement Scotland and NHS. Biosimilar medicines: a national prescribing framework. May 2015. http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/programme_resources/biosimilar_medicines_framework.aspx. Accessed 2 Oct 2016.
    • (2015) May
    • Scotland, H.I.1
  • 65
    • 85016998329 scopus 로고    scopus 로고
    • Guide to biosimilars for healthcare professionals and patients
    • Health Products Regulatory Agency (Ireland). Guide to biosimilars for healthcare professionals and patients. December 2015. https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-biosimilars-for-healthcare-professionals-and-patients-v2.pdf?sfvrsn=18. Accessed 2 Oct 2016.
    • (2015) December
  • 66
    • 85013300319 scopus 로고    scopus 로고
    • Update December 2015. Accessed 13 Oct 2016.
    • Position of Paul-Ehrlich-Institute regarding the use of biosimilars. Update December 2015. http://www.pei.de/EN/medicinal-products/antibodies-immunoglobulins-fusion-proteins/monoclonal-antibodies/biosimilars/position-pei-interchangebility-biosimilars-content.html. Accessed 13 Oct 2016.
    • (2015) Position of Paul-Ehrlich-Institute regarding the use of biosimilars


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.