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Volumn 34, Issue 4, 2016, Pages 698-705

Biosimilar monoclonal antibodies: Preclinical and clinical development aspects

Author keywords

Ankylosing spondylitis; Anti rheumatic agents; Biosimilar pharmaceuticals; CT P13; Inflammatory bowel disease; Rheumatoid arthritis; Therapeutic equivalence

Indexed keywords

ADALIMUMAB; BIOSIMILAR AGENT; DRUG ANTIBODY; FC RECEPTOR; INFLIXIMAB; MONOCLONAL ANTIBODY; NEUTRALIZING ANTIBODY; RITUXIMAB; TUMOR NECROSIS FACTOR; ANTIINFLAMMATORY AGENT; ANTIRHEUMATIC AGENT; GASTROINTESTINAL AGENT; GENERIC DRUG;

EID: 84984813317     PISSN: 0392856X     EISSN: 1593098X     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (27)

References (57)
  • 1
    • 84984830132 scopus 로고    scopus 로고
    • (Accessed 3 January 2016)
    • US FOOD AND DRUG ADMINISTRATION: Biosimilars. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/How-DrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/(Accessed 3 January 2016).
  • 6
    • 84870535043 scopus 로고    scopus 로고
    • Guidance for Industry (Accessed 5 September 2015)
    • US FOOD AND DRUG ADMINISTRATION: Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for Industry. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf (Accessed 5 September 2015).
    • Scientific considerations in demonstrating biosimilarity to a reference product
  • 7
    • 84862581676 scopus 로고    scopus 로고
    • Comparability and biosimilarity: considerations for the healthcare provider
    • LEE JF, LITTEN JB, GRAMPP G: Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin 2012; 28: 1053-8.
    • (2012) Curr Med Res Opin , vol.28 , pp. 1053-1058
    • Lee, J.F.1    Litten, J.B.2    Grampp, G.3
  • 8
    • 84882957437 scopus 로고    scopus 로고
    • Anti-neoplastic biosimilars-the same rules as for cytotoxic generics cannot be applied
    • MELLSTEDT H: Anti-neoplastic biosimilars-the same rules as for cytotoxic generics cannot be applied. Ann Onc 2013; 24 (Suppl. 5): v23-8.
    • (2013) Ann Onc , vol.24 , pp. v23-v28
    • Mellstedt, H.1
  • 10
    • 84896495229 scopus 로고    scopus 로고
    • The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise
    • SCHIESTL M, LI J, ABAS A et al.: The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise. Biologicals 2014; 42: 128-32.
    • (2014) Biologicals , vol.42 , pp. 128-132
    • Schiestl, M.1    Li, J.2    Abas, A.3
  • 11
    • 84891295368 scopus 로고    scopus 로고
    • Riskbased process development of biosimilars as part of the Quality by Design Paradigm
    • ZALAI D, DIETZSCH C, HERWIG C: Riskbased process development of biosimilars as part of the Quality by Design Paradigm. PDA J Pharm Sci Technol 2013; 67: 569-80.
    • (2013) PDA J Pharm Sci Technol , vol.67 , pp. 569-580
    • Zalai, D.1    Dietzsch, C.2    Herwig, C.3
  • 12
    • 79958811141 scopus 로고    scopus 로고
    • A new roadmap for biopharmaceutical drug product development: integrating development, validation, and quality by design
    • MARTIN-MOE S, LIM FJ, WONG RL, SREEDHARA A, SUNDARAM J, SANE SU: A new roadmap for biopharmaceutical drug product development: integrating development, validation, and quality by design. J Pharm Sci 2011; 100: 3031-43.
    • (2011) J Pharm Sci , vol.100 , pp. 3031-3043
    • Martin-Moe, S.1    Lim, F.J.2    Wong, R.L.3    Sreedhara, A.4    Sundaram, J.5    Sane, S.U.6
  • 14
    • 84871490375 scopus 로고    scopus 로고
    • (Accessed 1 October 2014)
    • EUROPEAN MEDICINES AGENCY: European assessment reports for authorised medicinal products for human use. Available at: http://www.ema.europa.eu/ema/index.jsp?curl_pages/medicines/landing/epar_search.jsp&murl_menus/medicines/medicines.jsp&mid_WC0b01ac058001d125 (Accessed 1 October 2014)
    • European assessment reports for authorised medicinal products for human use
  • 15
    • 84901920947 scopus 로고    scopus 로고
    • A Review of CT-P13: An infliximab biosimilar
    • 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
  • 16
    • 84875477617 scopus 로고    scopus 로고
    • The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?
    • McCAMISH M, WOOLLETT G: The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary? Clin Pharmacol Ther 2013; 93: 315-7.
    • (2013) Clin Pharmacol Ther , vol.93 , pp. 315-317
    • Mccamish, M.1    Woollett, G.2
  • 18
    • 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: 315-8.
    • (2013) Ann Rheum Dis , vol.72 , pp. 315-318
    • Schneider, C.K.1
  • 20
    • 83755207484 scopus 로고    scopus 로고
    • Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing: The REMICADE® Story
    • ABHINAV A. SHUKLA, MARK R. ETZEL, SHISHIR GADAM, (Eds). CRC Press
    • WOJCIECHOWSKI PW, SMIT HI, MYERS MM et al.: Making changes to a biopharmaceutical manufacturing process during development and commercial manufacturing: The REMICADE® Story. In ABHINAV A. SHUKLA, MARK R. ETZEL, SHISHIR GADAM, (Eds): In Process Scale Bioseparations for the Pharmaceutical Industry. CRC Press 2006: 507-22.
    • (2006) Process Scale Bioseparations for the Pharmaceutical Industry , pp. 507-522
    • Wojciechowski, P.W.1    Smit, H.I.2    Myers, M.M.3
  • 22
    • 84876431319 scopus 로고    scopus 로고
    • Biosimilars in oncology: emerging and future benefits
    • AAPRO M, CORNES P: Biosimilars in oncology: emerging and future benefits. Eur J Oncol Pharm 2012; 6: 27-9.
    • (2012) Eur J Oncol Pharm , vol.6 , pp. 27-29
    • Aapro, M.1    Cornes, P.2
  • 24
    • 84864487642 scopus 로고    scopus 로고
    • Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer
    • AAPRO M, CORNES P, SUN D, ABRAHAM I: Comparative cost efficiency across the European G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in patients with cancer. Ther Adv Med Oncol 2012; 4: 95-105.
    • (2012) Ther Adv Med Oncol , vol.4 , pp. 95-105
    • Aapro, M.1    Cornes, P.2    Sun, D.3    Abraham, I.4
  • 25
    • 84871856579 scopus 로고    scopus 로고
    • A non-interventional study of biosimilar granulocyte colonystimulating factor as prophylaxis for chemotherapy-induced neutropenia in a community oncology centre
    • VERPOORT K, MOHLER TM: A non-interventional study of biosimilar granulocyte colonystimulating factor as prophylaxis for chemotherapy-induced neutropenia in a community oncology centre. Ther Adv Med Oncol 2012; 4: 289-93.
    • (2012) Ther Adv Med Oncol , vol.4 , pp. 289-293
    • Verpoort, K.1    Mohler, T.M.2
  • 27
    • 84871492817 scopus 로고    scopus 로고
    • Biosimilars: what clinicians should know
    • WEISE M, BIELSKY MC, de SMET K et al. Biosimilars: what clinicians should know. Blood 2012; 120: 5111-7.
    • (2012) Blood , vol.120 , pp. 5111-5117
    • Weise, M.1    Bielsky, M.C.2    De Smet, K.3
  • 28
    • 79952488808 scopus 로고    scopus 로고
    • Quality of original and biosimilar epoetin products
    • BRINKS V, HAWE A, BASMELEH AH et al.: Quality of original and biosimilar epoetin products. Pharm Res 2011; 28: 386-93.
    • (2011) Pharm Res , vol.28 , pp. 386-393
    • Brinks, V.1    Hawe, A.2    Basmeleh, A.H.3
  • 29
    • 79958824101 scopus 로고    scopus 로고
    • Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
    • PRADITPORNSILPA K, TIRANATHANAGUL K, KUPATAWINTU P et al.: Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int 2011; 80: 88-92.
    • (2011) Kidney Int , vol.80 , pp. 88-92
    • Praditpornsilpa, K.1    Tiranathanagul, K.2    Kupatawintu, P.3
  • 32
    • 67649932264 scopus 로고    scopus 로고
    • (Accessed 23 May 2013)
    • EUROPEAN MEDICINES AGENCY: Guideline on the Investigation of Bioequivalence. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf (Accessed 23 May 2013).
    • Guideline on the Investigation of Bioequivalence
  • 33
    • 84923354566 scopus 로고    scopus 로고
    • Comparative immunogenicity assessment: a critical consideration for biosimilar development
    • PM, ZOU L, SADHU C, SHEN WD, NOCK S: Comparative immunogenicity assessment: a critical consideration for biosimilar development. Bioanalysis 2015; 7: 373-81.
    • (2015) Bioanalysis , vol.7 , pp. 373-381
    • Zou, P.M.L.1    Sadhu, C.2    Shen, W.D.3    Nock, S.4
  • 35
    • 84875477617 scopus 로고    scopus 로고
    • The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary?
    • McCAMISH M, WOOLLETT G: The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary? Clin Pharmacol Ther 2013; 93: 315-7.
    • (2013) Clin Pharmacol Ther , vol.93 , pp. 315-317
    • Mccamish, M.1    Woollett, G.2
  • 36
    • 84984788822 scopus 로고    scopus 로고
    • (Accessed 1 October 2014)
    • EUROPEAN MEDICINES AGENCY: Assessment report-Inflectra. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf (Accessed 1 October 2014).
    • Assessment report-Inflectra
  • 37
    • 0042991479 scopus 로고    scopus 로고
    • Differential p38 mitogen-activated protein kinase target phosphorylation in responders and nonresponders to infliximab
    • WAETZIG GH, ROSENSTIEL P, NIKOLAUS S, SEEGERT D, SCHREIBER S: Differential p38 mitogen-activated protein kinase target phosphorylation in responders and nonresponders to infliximab. Gastroenterology 2003; 125: 633-4.
    • (2003) Gastroenterology , vol.125 , pp. 633-634
    • Waetzig, G.H.1    Rosenstiel, P.2    Nikolaus, S.3    Seegert, D.4    Schreiber, S.5
  • 38
    • 43949126520 scopus 로고    scopus 로고
    • Mechanisms for cytotoxic effects of antitumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: comparison among infliximab, etanercept, and adalimumab
    • MITOMA H, HORIUCHI T, TSUKAMOTO H et al.: Mechanisms for cytotoxic effects of antitumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum 2008; 58: 1248-57.
    • (2008) Arthritis Rheum , vol.58 , pp. 1248-1257
    • Mitoma, H.1    Horiuchi, T.2    Tsukamoto, H.3
  • 39
    • 84876502612 scopus 로고    scopus 로고
    • FCGR3A-158 polymorphism influences the biological response to infliximab in Crohn's disease through affecting the ADCC activity
    • MOROI R, ENDO K, KINOUCHI Y et al.: FCGR3A-158 polymorphism influences the biological response to infliximab in Crohn's disease through affecting the ADCC activity. Immunogenetics 2013; 65: 265-71.
    • (2013) Immunogenetics , vol.65 , pp. 265-271
    • Moroi, R.1    Endo, K.2    Kinouchi, Y.3
  • 40
    • 84913533583 scopus 로고    scopus 로고
    • Physicochemical characterization of Remsima®
    • SOON KWAN JUNG, KYOUNG HOON LEE, JAE WON JEON et al.: Physicochemical characterization of Remsima®. mAbs 2014; 6: 1163-77.
    • (2014) mAbs , vol.6 , pp. 1163-1177
    • Jung, S.K.1    Lee, K.H.2    Jeon, J.W.3
  • 41
    • 84960085822 scopus 로고    scopus 로고
    • Biosimilar DMARDs: What does the future hold?
    • Mar 3 [Epub ahead of print]
    • ARAúJO F, GONçALVES J, FONSECA JE: Biosimilar DMARDs: What does the future hold? Drugs 2016 Mar 3 [Epub ahead of print].
    • (2016) Drugs
    • Araújo, F.1    Gonçalves, J.2    Fonseca, J.E.3
  • 42
    • 84942262036 scopus 로고    scopus 로고
    • Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima
    • Apr 20 [Epub ahead of print]
    • 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 2015 Apr 20 [Epub ahead of print].
    • (2015) Gut
    • Ben-Horin, S.1    Yavzori, M.2    Benhar, I.3
  • 43
    • 84942325078 scopus 로고    scopus 로고
    • Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea
    • PARK SH, KIM YH, LEE JU et al.: Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol 2015; (S1): 35-44.
    • (2015) Expert Rev Gastroenterol Hepatol , pp. 35-44
    • Park, S.H.1    Kim, Y.H.2    Lee, J.U.3
  • 44
    • 84940081554 scopus 로고    scopus 로고
    • Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study
    • May 14 [Epub ahead of print]
    • JUNG Y S, PARK D I, KIM Y H et al.: Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol 2015 May 14 [Epub ahead of print].
    • (2015) J Gastroenterol Hepatol
    • Jung, Y.S.1    Park, D.I.2    Kim, Y.H.3
  • 45
    • 84934294253 scopus 로고    scopus 로고
    • Clinical experience of the use of CTP13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series
    • KANG YS, MOON HH, LEE SE, LIM YJ, KANG HW: Clinical experience of the use of CTP13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci 2015; 60: 951-6.
    • (2015) Dig Dis Sci , vol.60 , pp. 951-956
    • Kang, Y.S.1    Moon, H.H.2    Lee, S.E.3    Lim, Y.J.4    Kang, H.W.5
  • 46
    • 84942310322 scopus 로고    scopus 로고
    • Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort
    • GECSE K, FARKAS K, LOVASZ B et al.: Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. J Crohns Colitis 2015; 9(S1): S234-5; P314.
    • (2015) J Crohns Colitis , vol.9
    • Gecse, K.1    Farkas, K.2    Lovasz, B.3
  • 47
    • 84942307002 scopus 로고    scopus 로고
    • Efficacy of the new infliximab biomarker CTP13 induction therapy on mucosal healing in ulcerative colitis patients
    • MOLNAR T, FARKAS K, RUTKA M et al.: Efficacy of the new infliximab biomarker CTP13 induction therapy on mucosal healing in ulcerative colitis patients. J Crohns Colitis 2015; 9(S1): S382; P603.
    • (2015) J Crohns Colitis , vol.9 , pp. S382
    • Molnar, T.1    Farkas, K.2    Rutka, M.3
  • 48
    • 84942303588 scopus 로고    scopus 로고
    • Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study
    • JAHNSEN J, DETLIE TE, VATN S, RICANEK P: Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study. Expert Rev Gastroenterol Hepatol 2015; 9(S1): 45-52.
    • (2015) Expert Rev Gastroenterol Hepatol , vol.9 , pp. 45-52
    • Jahnsen, J.1    Detlie, T.E.2    Vatn, S.3    Ricanek, P.4
  • 49
    • 84942324133 scopus 로고    scopus 로고
    • First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population
    • JARZEBICKA D, PLOCEK A, SIECZKOWSKA J et al.: First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. J Crohns Colitis 2015; 9(S1): S307-8; P456.
    • (2015) J Crohns Colitis , vol.9
    • Jarzebicka, D.1    Plocek, A.2    Sieczkowska, J.3
  • 50
    • 84942323927 scopus 로고    scopus 로고
    • Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report
    • SIECZKOWSKA J, BANASZKIEWICZ A, PLOCEK A et al.: Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report. J Crohns Colitis 2015; 9(S1): S295; P430.
    • (2015) J Crohns Colitis , vol.9
    • Sieczkowska, J.1    Banaszkiewicz, A.2    Plocek, A.3
  • 51
    • 84942313768 scopus 로고    scopus 로고
    • Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients
    • JARZEBICKA D, BANASZKIEWICZ A, PLOCEK A et al.: Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. J Crohns Colitis 2015; 9(S1): S224-5; P295
    • (2015) J Crohns Colitis , vol.9
    • Jarzebicka, D.1    Banaszkiewicz, A.2    Plocek, A.3
  • 53
    • 84942307684 scopus 로고    scopus 로고
    • The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13
    • REINISCH W, LOUIS E, DANESE S: The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13. Expert Rev Gastroenterol Hepatol 2015; 9(S1): 17-26.
    • (2015) Expert Rev Gastroenterol Hepatol , vol.9 , pp. 17-26
    • Reinisch, W.1    Louis, E.2    Danese, S.3
  • 54
    • 84894594811 scopus 로고    scopus 로고
    • Developing Clinical Trials for Biosimilars
    • BUI LA, TAYLOR C: Developing Clinical Trials for Biosimilars. Semin Oncol 2014; 41: S15-S25.
    • (2014) Semin Oncol , vol.41 , pp. S15-S25
    • Bui, L.A.1    Taylor, C.2
  • 55
    • 84883880492 scopus 로고    scopus 로고
    • Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry
    • BECK A, REICHERT JM: Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. mAbs 2013; 5: 621-3.
    • (2013) mAbs , vol.5 , pp. 621-623
    • Beck, A.1    Reichert, J.M.2
  • 56
    • 85018192777 scopus 로고    scopus 로고
    • Biosimilars: what do patients need to consider?
    • SKINGLE D: Biosimilars: what do patients need to consider? RMD Open 2015; 1: e000141.
    • (2015) RMD Open , vol.1
    • Skingle, D.1
  • 57
    • 84949626656 scopus 로고    scopus 로고
    • Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody
    • ISAACS JD, CUTOLO M, KEYSTONE EC, PARK W, BRAUN J: Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. J Intern Med 2016; 279: 41-59.
    • (2016) J Intern Med , vol.279 , pp. 41-59
    • Isaacs, J.D.1    Cutolo, M.2    Keystone, E.C.3    Park, W.4    Braun, J.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.