메뉴 건너뛰기




Volumn 17, Issue 11, 2016, Pages e502-e509

Safety and efficacy of biosimilars in oncology

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; BIOSIMILAR AGENT; CERTOLIZUMAB PEGOL; CT P13; ETANERCEPT; FILGRASTIM; GOLIMUMAB; INFLIXIMAB; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY SB2; MYL 14010; RECOMBINANT ERYTHROPOIETIN; RITUXIMAB; TAXANE DERIVATIVE; TRASTUZUMAB; UNCLASSIFIED DRUG; CT-P13;

EID: 84995704268     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(16)30374-6     Document Type: Review
Times cited : (54)

References (66)
  • 1
    • 79961203419 scopus 로고    scopus 로고
    • Biosimilars-why terminology matters
    • 1 Weise, M, Bielsky, MC, De Smet, K, et al. Biosimilars-why terminology matters. Nat Biotechnol 29 (2011), 690–693.
    • (2011) Nat Biotechnol , vol.29 , pp. 690-693
    • Weise, M.1    Bielsky, M.C.2    De Smet, K.3
  • 2
    • 84937411096 scopus 로고    scopus 로고
    • Production of biopharmaceuticals in E. coli: current scenario and future perspectives
    • 2 Baeshen, MN, Al-Hejin, AM, Bora, RS, et al. Production of biopharmaceuticals in E. coli: current scenario and future perspectives. J Microbiol Biotechnol 25 (2015), 953–962.
    • (2015) J Microbiol Biotechnol , vol.25 , pp. 953-962
    • Baeshen, M.N.1    Al-Hejin, A.M.2    Bora, R.S.3
  • 3
    • 80051711268 scopus 로고    scopus 로고
    • Industry and regulatory experience of the glycosylation of monoclonal antibodies
    • 3 Read, EK, Park, JT, Brorson, KA, Industry and regulatory experience of the glycosylation of monoclonal antibodies. Biotechnol Appl Biochem 58 (2011), 213–219.
    • (2011) Biotechnol Appl Biochem , vol.58 , pp. 213-219
    • Read, E.K.1    Park, J.T.2    Brorson, K.A.3
  • 5
    • 0036499495 scopus 로고    scopus 로고
    • ‘Biogenerics’: the off-patent biotech products
    • 5 Schellekens, H, Ryff, JC, ‘Biogenerics’: the off-patent biotech products. Trends Pharmacol Sci 23 (2002), 119–121.
    • (2002) Trends Pharmacol Sci , vol.23 , pp. 119-121
    • Schellekens, H.1    Ryff, J.C.2
  • 6
    • 33644952525 scopus 로고    scopus 로고
    • EMA Guideline on similar biological medicinal products, CHMP/437/04
    • (accessed Sept 29, 2016). Oct 30
    • 6 European Medicines Agency. EMA Guideline on similar biological medicinal products, CHMP/437/04. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf, Oct 30, 2005 (accessed Sept 29, 2016).
    • (2005)
  • 7
    • 84939805284 scopus 로고    scopus 로고
    • Biosimilar regulation in the EU
    • 7 Kurki, P, Ekman, N, Biosimilar regulation in the EU. Expert Rev Clin Pharmacol 8 (2015), 649–659.
    • (2015) Expert Rev Clin Pharmacol , vol.8 , pp. 649-659
    • Kurki, P.1    Ekman, N.2
  • 8
    • 0344668586 scopus 로고    scopus 로고
    • Pure red cell aplasia and anti-erythropoietin antibodies in patients treated with epoetin
    • 8 Casadevall, N, Pure red cell aplasia and anti-erythropoietin antibodies in patients treated with epoetin. Nephrol Dial Transplant 18:suppl 8 (2003), 37–41.
    • (2003) Nephrol Dial Transplant , vol.18 , pp. 37-41
    • Casadevall, N.1
  • 9
    • 84862581676 scopus 로고    scopus 로고
    • Comparability and biosimilarity: considerations for the healthcare provider
    • 9 Lee, JF, Litten, JB, Grampp, G, Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin 28 (2012), 1053–1058.
    • (2012) Curr Med Res Opin , vol.28 , pp. 1053-1058
    • Lee, J.F.1    Litten, J.B.2    Grampp, G.3
  • 10
    • 84882957437 scopus 로고    scopus 로고
    • Anti-neoplastic biosimilar—the same rules as for cytotoxic generics cannot be applied
    • 10 Mellstedt, H, Anti-neoplastic biosimilar—the same rules as for cytotoxic generics cannot be applied. Ann Oncol 24:suppl 5 (2013), 23–28.
    • (2013) Ann Oncol , vol.24 , pp. 23-28
    • Mellstedt, H.1
  • 12
    • 45949108207 scopus 로고    scopus 로고
    • WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19–20 April 2007
    • 12 Joung, J, Robertson, JS, Griffiths, E, Knezevic, I, WHO Informal Consultation Group. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19–20 April 2007. Biologicals 36 (2008), 269–276.
    • (2008) Biologicals , vol.36 , pp. 269-276
    • Joung, J.1    Robertson, J.S.2    Griffiths, E.3    Knezevic, I.4
  • 13
    • 84995702166 scopus 로고    scopus 로고
    • About GaBI
    • (accessed May 11, 2016).
    • 13 Generics and Biosimilars Initiative. About GaBI. http://gabionline.net/About-GaBI, 2015 (accessed May 11, 2016).
    • (2015)
  • 14
    • 84857233319 scopus 로고    scopus 로고
    • The state of the art in the development of biosimilars
    • 14 McCamish, M, Woollett, G, The state of the art in the development of biosimilars. Clin Pharmacol Ther 91 (2012), 405–417.
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 405-417
    • McCamish, M.1    Woollett, G.2
  • 15
    • 79952744875 scopus 로고    scopus 로고
    • Worldwide experience with biosimilar development
    • 15 McCamish, M, Woollett, G, Worldwide experience with biosimilar development. MAbs 3 (2011), 209–217.
    • (2011) MAbs , vol.3 , pp. 209-217
    • McCamish, M.1    Woollett, G.2
  • 16
    • 42049123626 scopus 로고    scopus 로고
    • EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
    • (accessed May 23, 2016).
    • 16 European Medicines Agency. EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf, 2006 (accessed May 23, 2016).
    • (2006)
  • 17
    • 84942234810 scopus 로고    scopus 로고
    • Guidance for industry scientific considerations in demonstrating biosimilarity to a reference product
    • (accessed May 23, 2016).
    • 17 US Department of Health and Human Services. Guidance for industry scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf, 2015 (accessed May 23, 2016).
    • (2015)
  • 18
    • 84870935790 scopus 로고    scopus 로고
    • Setting the stage for biosimilar monoclonal antibodies
    • 18 Schneider, CK, Vleminckx, C, Gravanis, I, et al. Setting the stage for biosimilar monoclonal antibodies. Nat Biotechnol 30 (2012), 1179–1185.
    • (2012) Nat Biotechnol , vol.30 , pp. 1179-1185
    • Schneider, C.K.1    Vleminckx, C.2    Gravanis, I.3
  • 19
    • 84995662976 scopus 로고    scopus 로고
    • European Public Assessment Reports—biosimilars
    • (accessed July 8, 2016).
    • 19 European Medicines Agency. European Public Assessment Reports—biosimilars. http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit (accessed July 8, 2016).
  • 21
    • 0036467826 scopus 로고    scopus 로고
    • Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer
    • 21 Vogel, CL, Cobleigh, MA, Tripathy, D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 20 (2002), 719–726.
    • (2002) J Clin Oncol , vol.20 , pp. 719-726
    • Vogel, C.L.1    Cobleigh, M.A.2    Tripathy, D.3
  • 22
    • 0035169514 scopus 로고    scopus 로고
    • Rituximab (anti-CD20 monoclonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden: clinical and molecular evaluation
    • 22 Colombat, P, Salles, G, Brousse, N, et al. Rituximab (anti-CD20 monoclonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden: clinical and molecular evaluation. Blood 97 (2001), 101–106.
    • (2001) Blood , vol.97 , pp. 101-106
    • Colombat, P.1    Salles, G.2    Brousse, N.3
  • 23
    • 20044362555 scopus 로고    scopus 로고
    • Rituximab therapy for patients with newly diagnosed, advanced-stage, follicular grade I non-Hodgkin's lymphoma: a phase II trial in the North Central Cancer Treatment Group
    • 23 Witzig, TE, Vukov, AM, Habermann, TM, et al. Rituximab therapy for patients with newly diagnosed, advanced-stage, follicular grade I non-Hodgkin's lymphoma: a phase II trial in the North Central Cancer Treatment Group. J Clin Oncol 23 (2005), 1103–1108.
    • (2005) J Clin Oncol , vol.23 , pp. 1103-1108
    • Witzig, T.E.1    Vukov, A.M.2    Habermann, T.M.3
  • 24
    • 85054537468 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
    • (accessed May 11, 2016).
    • 24 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf, 2015 (accessed May 11, 2016).
    • (2015)
  • 25
    • 84995662975 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP) Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor
    • (accessed May 11, 2016).
    • 25 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/07/WC500190635.pdf, 2005 (accessed May 11, 2016).
    • (2005)
  • 26
    • 84865489427 scopus 로고    scopus 로고
    • Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance?
    • 26 Kooijman, M, van Meer, PJ, Moors, EH, Schellekens, H, Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance?. Expert Opin Drug Saf 11 (2012), 797–801.
    • (2012) Expert Opin Drug Saf , vol.11 , pp. 797-801
    • Kooijman, M.1    van Meer, P.J.2    Moors, E.H.3    Schellekens, H.4
  • 27
  • 28
    • 84899948126 scopus 로고    scopus 로고
    • The association of psoriasiform rash with anti-tumor necrosis factor (anti-TNF) therapy in inflammatory bowel disease: a single academic center case series
    • 28 Afzali, A, Wheat, CL, Hu, JK, Olerud, JE, Lee, SD, The association of psoriasiform rash with anti-tumor necrosis factor (anti-TNF) therapy in inflammatory bowel disease: a single academic center case series. J Crohns Colitis 8 (2014), 480–488.
    • (2014) J Crohns Colitis , vol.8 , pp. 480-488
    • Afzali, A.1    Wheat, C.L.2    Hu, J.K.3    Olerud, J.E.4    Lee, S.D.5
  • 29
    • 84923354566 scopus 로고    scopus 로고
    • Comparative immunogenicity assessment: a critical consideration for biosimilar development
    • 29 Liu, PM, Zou, L, Sadhu, C, Shen, WD, Nock, S, Comparative immunogenicity assessment: a critical consideration for biosimilar development. Bioanalysis 7 (2015), 373–381.
    • (2015) Bioanalysis , vol.7 , pp. 373-381
    • Liu, P.M.1    Zou, L.2    Sadhu, C.3    Shen, W.D.4    Nock, S.5
  • 30
  • 31
    • 84973896889 scopus 로고    scopus 로고
    • Cross-immunogenicity: antibodies to infliximab in remicade-treated patients with IBD similarly recognise the biosimilar Remsima
    • 31 Ben-Horin, S, Yavzori, M, Benhar, I, et al. Cross-immunogenicity: antibodies to infliximab in remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut 65 (2016), 1132–1138.
    • (2016) Gut , vol.65 , pp. 1132-1138
    • Ben-Horin, S.1    Yavzori, M.2    Benhar, I.3
  • 32
    • 84870385642 scopus 로고    scopus 로고
    • Comparison of long-term clinical outcome with etanercept treatment and adalimumab treatment of rheumatoid arthritis with respect to immunogenicity
    • 32 Krieckaert, CL, Jamnitski, A, Nurmohamed, MT, Kostense, PJ, Boers, M, Wolbink, G, Comparison of long-term clinical outcome with etanercept treatment and adalimumab treatment of rheumatoid arthritis with respect to immunogenicity. Arthritis Rheum 64 (2012), 3850–3855.
    • (2012) Arthritis Rheum , vol.64 , pp. 3850-3855
    • Krieckaert, C.L.1    Jamnitski, A.2    Nurmohamed, M.T.3    Kostense, P.J.4    Boers, M.5    Wolbink, G.6
  • 33
    • 84955182846 scopus 로고    scopus 로고
    • Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety?
    • 33 Murdaca, G, Spanò, F, Contatore, M, et al. Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety?. Expert Opin Drug Saf 15 (2016), 43–52.
    • (2016) Expert Opin Drug Saf , vol.15 , pp. 43-52
    • Murdaca, G.1    Spanò, F.2    Contatore, M.3
  • 34
    • 84890088509 scopus 로고    scopus 로고
    • The INN crowd
    • 34 The INN crowd. Nat Biotechnol, 31, 2013, 1055.
    • (2013) Nat Biotechnol , vol.31 , pp. 1055
  • 35
    • 84953403470 scopus 로고    scopus 로고
    • The constrained prescription, interchangeability and substitution of biosimilars
    • 35 Minghetti, P, Rocco, P, Schellekens, H, The constrained prescription, interchangeability and substitution of biosimilars. Nat Biotechnol 33 (2015), 688–689.
    • (2015) Nat Biotechnol , vol.33 , pp. 688-689
    • Minghetti, P.1    Rocco, P.2    Schellekens, H.3
  • 36
    • 84970968764 scopus 로고    scopus 로고
    • Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications
    • 36 Dowlat, HA, Kuhlmann, MK, Khatami, H, Ampudia-Blasco, FJ, Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications. Diabetes Obes Metab 18 (2016), 737–746.
    • (2016) Diabetes Obes Metab , vol.18 , pp. 737-746
    • Dowlat, H.A.1    Kuhlmann, M.K.2    Khatami, H.3    Ampudia-Blasco, F.J.4
  • 37
    • 84995597597 scopus 로고    scopus 로고
    • EU guidelines for biosimilars
    • (accessed May 11, 2016).
    • 37 Generics and Biosimilars Initiative. EU guidelines for biosimilars. http://gabionline.net/Guidelines/EU-guidelines-for-biosimilars, 2010 (accessed May 11, 2016).
    • (2010)
  • 38
  • 39
    • 84946495972 scopus 로고    scopus 로고
    • Biosimilar monoclonal antibodies: the scientific basis for extrapolation
    • 39 Schellekens, H, Lietzan, E, Faccin, F, Venema, J, Biosimilar monoclonal antibodies: the scientific basis for extrapolation. Expert Opin Biol Ther 15 (2015), 1633–1646.
    • (2015) Expert Opin Biol Ther , vol.15 , pp. 1633-1646
    • Schellekens, H.1    Lietzan, E.2    Faccin, F.3    Venema, J.4
  • 40
    • 84894289194 scopus 로고    scopus 로고
    • ECCO position challenged by European drug regulators
    • 40 Kurki, P, Bielsky, MC, ECCO position challenged by European drug regulators. J Crohns Colitis, 8, 2014, 258.
    • (2014) J Crohns Colitis , vol.8 , pp. 258
    • Kurki, P.1    Bielsky, M.C.2
  • 41
    • 84889683813 scopus 로고    scopus 로고
    • Summary of opinion (infliximab biosimilar)
    • (accessed May 11, 2016).
    • 41 European Medicines Agency. Summary of opinion (infliximab biosimilar). http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002576/WC500144832.pdf, 2013 (accessed May 11, 2016).
    • (2013)
  • 42
    • 84883752718 scopus 로고    scopus 로고
    • A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study
    • 42 Yoo, DH, Hrycaj, P, Miranda, P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 72 (2013), 1613–1620.
    • (2013) Ann Rheum Dis , vol.72 , pp. 1613-1620
    • Yoo, D.H.1    Hrycaj, P.2    Miranda, P.3
  • 43
    • 84883746909 scopus 로고    scopus 로고
    • A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study
    • 43 Park, W, Hrycaj, P, Jeka, S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 72 (2013), 1605–1612.
    • (2013) Ann Rheum Dis , vol.72 , pp. 1605-1612
    • Park, W.1    Hrycaj, P.2    Jeka, S.3
  • 44
    • 85008258391 scopus 로고    scopus 로고
    • Norway, biosimilars in different funding systems. What works?
    • 44 Mack, A, Norway, biosimilars in different funding systems. What works?. GaBI J 4 (2015), 90–92.
    • (2015) GaBI J , vol.4 , pp. 90-92
    • Mack, A.1
  • 45
    • 84995662963 scopus 로고    scopus 로고
    • ViewPoints: Denmark joins Norway in securing a 60 percent-plus discount for biosimilar remicade—what impact on the rest of Europe?
    • (accessed July 8, 2016).
    • 45 FirstWord. ViewPoints: Denmark joins Norway in securing a 60 percent-plus discount for biosimilar remicade—what impact on the rest of Europe?. http://www.fwbiosimilars.com/viewpoints-denmark-joins-norway-securing-60-percent-plus-discount-biosimilar-remicade-%E2%80%93-what-impact (accessed July 8, 2016).
  • 46
    • 38549176118 scopus 로고    scopus 로고
    • Tumor necrosis factor antagonist mechanisms of action: a comprehensive review
    • 46 Tracey, D, Klareskog, L, Sasso, EH, Salfeld, JG, Tak, PP, Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 117 (2008), 244–279.
    • (2008) Pharmacol Ther , vol.117 , pp. 244-279
    • Tracey, D.1    Klareskog, L.2    Sasso, E.H.3    Salfeld, J.G.4    Tak, P.P.5
  • 47
    • 84900807640 scopus 로고    scopus 로고
    • The role of tumour necrosis factor in the pathogenesis of immune-mediated diseases
    • 47 Blandizzi, C, Gionchetti, P, Armuzzi, A, et al. The role of tumour necrosis factor in the pathogenesis of immune-mediated diseases. Int J Immunopathol Pharmacol 27:suppl 1 (2014), 1–10.
    • (2014) Int J Immunopathol Pharmacol , vol.27 , pp. 1-10
    • Blandizzi, C.1    Gionchetti, P.2    Armuzzi, A.3
  • 48
    • 84976231785 scopus 로고    scopus 로고
    • FirstWord Lists—the best selling drugs in 2014
    • (accessed July 8, 2016).
    • 48 King, S, FirstWord Lists—the best selling drugs in 2014. http://www.firstwordpharma.com/node/1263906#axzz3lWvxPzF4, 2015 (accessed July 8, 2016).
    • (2015)
    • King, S.1
  • 49
    • 84986295312 scopus 로고    scopus 로고
    • Safety profile of biologic drugs in the treatment of inflammatory bowel diseases: a systematic review and network meta-analysis of randomized controlled trials
    • published online Sept 7.
    • 49 Moćko, P, Kawalec, P, Pilc, A, Safety profile of biologic drugs in the treatment of inflammatory bowel diseases: a systematic review and network meta-analysis of randomized controlled trials. Clin Drug Investig, 2016, 10.1007/s40261-016-0459-y published online Sept 7.
    • (2016) Clin Drug Investig
    • Moćko, P.1    Kawalec, P.2    Pilc, A.3
  • 50
    • 84913533583 scopus 로고    scopus 로고
    • Physicochemical characterization of remsima
    • 50 Jung, SK, Lee, KH, Jeon, JW, et al. Physicochemical characterization of remsima. MAbs 6 (2014), 1163–1177.
    • (2014) MAbs , vol.6 , pp. 1163-1177
    • Jung, S.K.1    Lee, K.H.2    Jeon, J.W.3
  • 51
    • 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
    • published online April 29.
    • 51 Yoo, DH, Prodanovic, N, Jaworski, J, 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, 2016, 10.1136/annrheumdis-2015-208786 published online April 29.
    • (2016) Ann Rheum Dis
    • Yoo, D.H.1    Prodanovic, N.2    Jaworski, J.3
  • 52
    • 84965014483 scopus 로고    scopus 로고
    • Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study
    • published online April 26.
    • 52 Park, W, Yoo, DH, Miranda, P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis, 2016, 10.1136/annrheumdis-2015-208783 published online April 26.
    • (2016) Ann Rheum Dis
    • Park, W.1    Yoo, D.H.2    Miranda, P.3
  • 53
    • 84941584714 scopus 로고    scopus 로고
    • A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy
    • published online Aug 28.
    • 53 Choe, JY, Prodanovic, N, Niebrzydowski, J, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis, 2015, 10.1136/annrheumdis-2015-207764 published online Aug 28.
    • (2015) Ann Rheum Dis
    • Choe, J.Y.1    Prodanovic, N.2    Niebrzydowski, J.3
  • 54
    • 84937604672 scopus 로고    scopus 로고
    • A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy
    • published online July 6.
    • 54 Emery, P, Vencovský, J, Sylwestrzak, A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis, 2015, 10.1136/annrheumdis-2015-207588 published online July 6.
    • (2015) Ann Rheum Dis
    • Emery, P.1    Vencovský, J.2    Sylwestrzak, A.3
  • 55
    • 84878624235 scopus 로고    scopus 로고
    • ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)
    • 55 Danese, S, Gomollon, F, ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis 7 (2013), 586–589.
    • (2013) J Crohns Colitis , vol.7 , pp. 586-589
    • Danese, S.1    Gomollon, F.2
  • 56
    • 84954309076 scopus 로고    scopus 로고
    • Consistency of quality attributes for the glycosylated monoclonal antibody Humira(R) (adalimumab)
    • 56 Tebbey, PW, Varga, A, Naill, M, Clewell, J, Venema, J, Consistency of quality attributes for the glycosylated monoclonal antibody Humira(R) (adalimumab). MAbs 7 (2015), 805–811.
    • (2015) MAbs , vol.7 , pp. 805-811
    • Tebbey, P.W.1    Varga, A.2    Naill, M.3    Clewell, J.4    Venema, J.5
  • 57
    • 84977172984 scopus 로고    scopus 로고
    • HERITAGE: a phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus herceptin
    • abstr LBA503.
    • 57 Rugo, HS, Barve, A, Waller, CF, et al. HERITAGE: a phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus herceptin. Proc Am Soc Clin Oncol, 34(suppl), 2016 abstr LBA503.
    • (2016) Proc Am Soc Clin Oncol , vol.34
    • Rugo, H.S.1    Barve, A.2    Waller, C.F.3
  • 58
    • 84919337080 scopus 로고    scopus 로고
    • A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01)
    • 58 Yin, D, Barker, KB, Li, R, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol 78 (2014), 1281–1290.
    • (2014) Br J Clin Pharmacol , vol.78 , pp. 1281-1290
    • Yin, D.1    Barker, K.B.2    Li, R.3
  • 59
    • 84911972652 scopus 로고    scopus 로고
    • A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers
    • 59 Wisman, LA, De Cock, EP, Reijers, JA, et al. A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers. Clin Drug Investig 34 (2014), 887–894.
    • (2014) Clin Drug Investig , vol.34 , pp. 887-894
    • Wisman, L.A.1    De Cock, E.P.2    Reijers, J.A.3
  • 60
    • 84995548664 scopus 로고    scopus 로고
    • Comparative similarity of ABP 980 and trastuzumab: results of functional similarity and human pharmacokinetic assessment
    • P6-13-12 (abstr).
    • 60 Hanes, V, Born, T, Chow, V, et al. Comparative similarity of ABP 980 and trastuzumab: results of functional similarity and human pharmacokinetic assessment. Cancer Res, 76(suppl 4), 2016 P6-13-12 (abstr).
    • (2016) Cancer Res , vol.76
    • Hanes, V.1    Born, T.2    Chow, V.3
  • 61
    • 84957536720 scopus 로고    scopus 로고
    • Pharmacokinetic bioequivalence, safety, and immunogenicity of DMB-3111, a trastuzumab biosimilar, and trastuzumab in healthy Japanese adult males: results of a randomized trial
    • 61 Morita, J, Tanaka, M, Nomoto, M, et al. Pharmacokinetic bioequivalence, safety, and immunogenicity of DMB-3111, a trastuzumab biosimilar, and trastuzumab in healthy Japanese adult males: results of a randomized trial. BioDrugs 30 (2016), 17–25.
    • (2016) BioDrugs , vol.30 , pp. 17-25
    • Morita, J.1    Tanaka, M.2    Nomoto, M.3
  • 62
    • 84977646077 scopus 로고    scopus 로고
    • A randomized phase i pharmacokinetic study comparing biosimilar candidate SB3 and trastuzumab in healthy male subjects
    • 62 Pivot, X, Curtit, E, Lee, YJ, et al. A randomized phase i pharmacokinetic study comparing biosimilar candidate SB3 and trastuzumab in healthy male subjects. Clin Ther 38 (2016), 1665–1673.
    • (2016) Clin Ther , vol.38 , pp. 1665-1673
    • Pivot, X.1    Curtit, E.2    Lee, Y.J.3
  • 63
    • 84993790553 scopus 로고    scopus 로고
    • The evolving role of biosimilars in haematology-oncology: a practical perspective
    • 63 Gascon, P, The evolving role of biosimilars in haematology-oncology: a practical perspective. Ther Adv Hematol 6 (2015), 267–281.
    • (2015) Ther Adv Hematol , vol.6 , pp. 267-281
    • Gascon, P.1
  • 64
    • 84995650895 scopus 로고    scopus 로고
    • CT-P13 (infliximab biosimilar) briefing document for the Arthritis Advisory Committee
    • (accessed May 20, 2016).
    • 64 FDA. CT-P13 (infliximab biosimilar) briefing document for the Arthritis Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM484860.pdf, 2016 (accessed May 20, 2016).
    • (2016)
  • 66
    • 84995606624 scopus 로고    scopus 로고
    • Comparability of biotechnological/biological products subject to changes in their manufacturing process—Q5E
    • (accessed Sept 29, 2016).
    • 66 ICH Harmonized Tripartite Guideline. Comparability of biotechnological/biological products subject to changes in their manufacturing process—Q5E. http://www.ich.org/products/guidelines/quality/quality-single/article/comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-proc.html, 2004 (accessed Sept 29, 2016).
    • (2004)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.