메뉴 건너뛰기




Volumn 15, Issue 11, 2015, Pages 1633-1646

Biosimilar monoclonal antibodies: The scientific basis for extrapolation

Author keywords

biosimilars; extrapolation; infliximab; monoclonal antibodies; TNF inhibitors

Indexed keywords

BIOSIMILAR AGENT; FILGRASTIM; INFLIXIMAB; MONOCLONAL ANTIBODY; TNF PROTEIN, HUMAN; TUMOR NECROSIS FACTOR ALPHA;

EID: 84946495972     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2015.1083552     Document Type: Review
Times cited : (21)

References (51)
  • 6
    • 84893044719 scopus 로고    scopus 로고
    • Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?
    • Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014;16:22-6
    • (2014) AAPS J , vol.16 , pp. 22-26
    • Lee, H.1
  • 7
    • 84873635799 scopus 로고    scopus 로고
    • The role of biosimilars in the treatment of rheumatic diseases
    • Dorner T, Strand V, Castaneda-Hernandez G, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322-8
    • (2013) Ann Rheum Dis , vol.72 , pp. 322-328
    • Dorner, T.1    Strand, V.2    Castaneda-Hernandez, G.3
  • 10
    • 84923353114 scopus 로고    scopus 로고
    • Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation
    • Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: a Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol 2015;55:S123-32
    • (2015) J Clin Pharmacol , vol.55 , pp. S123-S132
    • Scott, B.J.1    Klein, A.V.2    Wang, J.3
  • 11
    • 36348937220 scopus 로고    scopus 로고
    • Biosimilar drugs: Concerns and opportunities
    • Genazzani AA, Biggio G, Caputi AP, et al. Biosimilar drugs: concerns and opportunities. BioDrugs 2007;21:351-6
    • (2007) BioDrugs , vol.21 , pp. 351-356
    • Genazzani, A.A.1    Biggio, G.2    Caputi, A.P.3
  • 12
    • 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
  • 13
    • 0037075272 scopus 로고    scopus 로고
    • Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
    • Casadevall N, Nataf J, 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.2    Viron, B.3
  • 14
    • 79960341709 scopus 로고    scopus 로고
    • Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics
    • Chow S-C, Endrenyi L, Lachenbruch PA, et al. Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars 2011;1:13-26
    • (2011) Biosimilars , vol.1 , pp. 13-26
    • Chow, S.-C.1    Endrenyi, L.2    Lachenbruch, P.A.3
  • 15
    • 35748959960 scopus 로고    scopus 로고
    • Pure red-cell aplasia "epidemic" - MYSTERY completely revealed?
    • Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia "epidemic" - mystery completely revealed? Perit Dial Int 2007;27:S303-7
    • (2007) Perit Dial Int , vol.27 , pp. S303-S307
    • Locatelli, F.1    Del Vecchio, L.2    Pozzoni, P.3
  • 19
    • 84904069611 scopus 로고    scopus 로고
    • The challenge of indication extrapolation for infliximab biosimilars
    • Feagan BG, Choquette D, Ghosh S, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014;42:177-83
    • (2014) Biologicals , vol.42 , pp. 177-183
    • Feagan, B.G.1    Choquette, D.2    Ghosh, S.3
  • 20
    • 84946511646 scopus 로고    scopus 로고
    • Available from: Last accessed 9 June 2015]
    • European Medicines Agency. 2015. Available from: http://www.ema.europa.eu/ema/ [Last accessed 9 June 2015]
    • (2015)
  • 21
    • 79955655456 scopus 로고    scopus 로고
    • Biosimilars 2.0: Guiding principles for a global "patients first" standard
    • Miletich J, Eich G, Grampp G, Mounho B. Biosimilars 2.0: guiding principles for a global "patients first" standard. mAbs 2011;3:318-25
    • (2011) MAbs , vol.3 , pp. 318-325
    • Miletich, J.1    Eich, G.2    Grampp, G.3    Mounho, B.4
  • 24
    • 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
    • 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 2013;72:1613-20
    • (2013) Ann Rheum Dis , vol.72 , pp. 1613-1620
    • Yoo, D.H.1    Hrycaj, P.2    Miranda, P.3
  • 25
    • 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
    • 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 2013;72:1605-12
    • (2013) Ann Rheum Dis , vol.72 , pp. 1605-1612
    • Park, W.1    Hrycaj, P.2    Jeka, S.3
  • 26
    • 84924657714 scopus 로고    scopus 로고
    • Available from: Last accessed 20 July 2014]
    • Health Canada. Summary basis of decision (SBD): Inflectra - 2014. 2014. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd-smd-2014-inflectra-159493-eng.php [Last accessed 20 July 2014]
    • (2014) Summary Basis of Decision (SBD): Inflectra - 2014
  • 27
    • 84879086432 scopus 로고    scopus 로고
    • Mechanisms of action of anti-tumor necrosis factor alpha agents in Crohn's disease
    • Peake ST, Bernardo D, Mann ER, et al. Mechanisms of action of anti-tumor necrosis factor alpha agents in Crohn's disease. Inflamm Bowel Dis 2013;19:1546-55
    • (2013) Inflamm Bowel Dis , vol.19 , pp. 1546-1555
    • Peake, S.T.1    Bernardo, D.2    Mann, E.R.3
  • 30
    • 84915770463 scopus 로고    scopus 로고
    • Defining critical quality attributes for monoclonal antibody therapeutic products
    • Rathore AS, Reason AJ, Weiskopf A. Defining critical quality attributes for monoclonal antibody therapeutic products. BioPharm International 2014;27:34-43
    • (2014) BioPharm International , vol.27 , pp. 34-43
    • Rathore, A.S.1    Reason, A.J.2    Weiskopf, A.3
  • 31
    • 84900873880 scopus 로고    scopus 로고
    • Biologics: An update and challenge of their pharmacokinetics
    • Shi S. Biologics: an update and challenge of their pharmacokinetics. Curr Drug Metab 2014;15:271-90
    • (2014) Curr Drug Metab , vol.15 , pp. 271-290
    • Shi, S.1
  • 32
    • 75149183678 scopus 로고    scopus 로고
    • Glycosylation of therapeutic proteins: An effective strategy to optimize efficacy
    • Sola RJ, Griebenow K. Glycosylation of therapeutic proteins: an effective strategy to optimize efficacy. BioDrugs 2010;24:9-21
    • (2010) BioDrugs , vol.24 , pp. 9-21
    • Sola, R.J.1    Griebenow, K.2
  • 33
    • 84883746643 scopus 로고    scopus 로고
    • Biosimilars to treat inflammatory arthritis: The challenge of proving identity
    • Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 2013;72:1589-93
    • (2013) Ann Rheum Dis , vol.72 , pp. 1589-1593
    • Kay, J.1    Smolen, J.S.2
  • 34
    • 33845660797 scopus 로고    scopus 로고
    • Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab
    • Bendtzen K, Geborek P, Svenson M, et al. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum 2006;54:3782-9
    • (2006) Arthritis Rheum , vol.54 , pp. 3782-3789
    • Bendtzen, K.1    Geborek, P.2    Svenson, M.3
  • 35
    • 3042579454 scopus 로고    scopus 로고
    • Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease
    • Hanauer SB, Wagner CL, Bala M, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol 2004;2:542-53
    • (2004) Clin Gastroenterol Hepatol , vol.2 , pp. 542-553
    • Hanauer, S.B.1    Wagner, C.L.2    Bala, M.3
  • 37
    • 67650137185 scopus 로고    scopus 로고
    • Dealing with immunogenicity of biologicals: Assessment and clinical relevance
    • Wolbink GJ, Aarden LA, Dijkmans BA. Dealing with immunogenicity of biologicals: assessment and clinical relevance. Curr Opin Rheumatol 2009;21:211-15
    • (2009) Curr Opin Rheumatol , vol.21 , pp. 211-215
    • Wolbink, G.J.1    Aarden, L.A.2    Dijkmans, B.A.3
  • 39
    • 0030954732 scopus 로고    scopus 로고
    • A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease
    • Crohn's disease cA2 study group
    • Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's disease cA2 study group. N Engl J Med 1997;337:1029-35
    • (1997) N Engl J Med , vol.337 , pp. 1029-1035
    • Targan, S.R.1    Hanauer, S.B.2    Van Deventer, S.J.3
  • 40
    • 0037018761 scopus 로고    scopus 로고
    • Maintenance infliximab for Crohn's disease: The ACCENT I randomised trial
    • Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002;359:1541-9
    • (2002) Lancet , vol.359 , pp. 1541-1549
    • Hanauer, S.B.1    Feagan, B.G.2    Lichtenstein, G.R.3
  • 41
    • 0033529049 scopus 로고    scopus 로고
    • Infliximab for the treatment of fistulas in patients with Crohn's disease
    • Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999;340:1398-405
    • (1999) N Engl J Med , vol.340 , pp. 1398-1405
    • Present, D.H.1    Rutgeerts, P.2    Targan, S.3
  • 42
    • 10744221312 scopus 로고    scopus 로고
    • Infliximab maintenance therapy for fistulizing Crohn's disease
    • Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004;350:876-85
    • (2004) N Engl J Med , vol.350 , pp. 876-885
    • Sands, B.E.1    Anderson, F.H.2    Bernstein, C.N.3
  • 43
    • 28844473957 scopus 로고    scopus 로고
    • Infliximab for induction and maintenance therapy for ulcerative colitis
    • Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353:2462-76
    • (2005) N Engl J Med , vol.353 , pp. 2462-2476
    • Rutgeerts, P.1    Sandborn, W.J.2    Feagan, B.G.3
  • 44
    • 0034735842 scopus 로고    scopus 로고
    • Infliximab and methotrexate in the treatment of rheumatoid arthritis
    • Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group
    • Lipsky PE, van der Heijde DM, St Clair EW, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000;343:1594-602
    • (2000) N Engl J Med , vol.343 , pp. 1594-1602
    • Lipsky, P.E.1    Van Der Heijde, D.M.2    St Clair, E.W.3
  • 45
    • 8444239359 scopus 로고    scopus 로고
    • Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: A randomized, controlled trial
    • St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004;50:3432-43
    • (2004) Arthritis Rheum , vol.50 , pp. 3432-3443
    • St Clair, E.W.1    Van Der Heijde, D.M.2    Smolen, J.S.3
  • 46
    • 13444253765 scopus 로고    scopus 로고
    • Efficacy and safety of infliximab in patients with ankylosing spondylitis: Results of a randomized, placebo-controlled trial (ASSERT)
    • van der Heijde D, Dijkmans B, Geusens P, et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005;52:582-91
    • (2005) Arthritis Rheum , vol.52 , pp. 582-591
    • Van Der Heijde, D.1    Dijkmans, B.2    Geusens, P.3
  • 47
    • 20244376625 scopus 로고    scopus 로고
    • Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: Results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT)
    • Antoni CE, Kavanaugh A, Kirkham B, et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum 2005;52:1227-36
    • (2005) Arthritis Rheum , vol.52 , pp. 1227-1236
    • Antoni, C.E.1    Kavanaugh, A.2    Kirkham, B.3
  • 48
    • 19044382942 scopus 로고    scopus 로고
    • Infliximab improves signs and symptoms of psoriatic arthritis: Results of the IMPACT 2 trial
    • Antoni C, Krueger GG, de Vlam K, et al. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis 2005;64:1150-7
    • (2005) Ann Rheum Dis , vol.64 , pp. 1150-1157
    • Antoni, C.1    Krueger, G.G.2    De Vlam, K.3
  • 49
    • 26644433889 scopus 로고    scopus 로고
    • Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: A phase III, multicentre, double-blind trial
    • Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005;366:1367-74
    • (2005) Lancet , vol.366 , pp. 1367-1374
    • Reich, K.1    Nestle, F.O.2    Papp, K.3
  • 50
    • 33845692734 scopus 로고    scopus 로고
    • A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis
    • Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007;56:31e1-15
    • (2007) J Am Acad Dermatol , vol.56 , pp. 31e1-31e15
    • Menter, A.1    Feldman, S.R.2    Weinstein, G.D.3
  • 51
    • 4644327125 scopus 로고    scopus 로고
    • Infliximab induction therapy for patients with severe plaque-type psoriasis: A randomized, double-blind, placebo-controlled trial
    • Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol 2004;51:534-42
    • (2004) J Am Acad Dermatol , vol.51 , pp. 534-542
    • Gottlieb, A.B.1    Evans, R.2    Li, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.