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Volumn 30, Issue 4, 2016, Pages 339-351

Demonstration of Functional Similarity of Proposed Biosimilar ABP 501 to Adalimumab

Author keywords

[No Author keywords available]

Indexed keywords

ABP 501; ADALIMUMAB; BIOSIMILAR AGENT; CASPASE; FC RECEPTOR; FC RECEPTOR IA; FC RECEPTOR IIA; FC RECEPTOR IIIA; IMMUNOGLOBULIN G1 ANTIBODY; INTERLEUKIN 8; LYMPHOTOXIN; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG; FC RECEPTOR, NEONATAL; HLA ANTIGEN CLASS 1; TUMOR NECROSIS FACTOR;

EID: 84978924417     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-016-0185-2     Document Type: Article
Times cited : (43)

References (32)
  • 1
    • 33847676571 scopus 로고    scopus 로고
    • US Centers for Medicare and Medicaid Services, Accessed 10 Apr 2015
    • US Centers for Medicare and Medicaid Services. National health expenditures 2013 highlights. http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/highlights.pdf. Accessed 10 Apr 2015.
    • National health expenditures 2013 highlights
  • 3
    • 84870535043 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry. Accessed 12 May 2015
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed 12 May 2015.
    • Scientific considerations in demonstrating biosimilarity to a reference product
  • 4
    • 0345424863 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Accessed 25 Feb 2015
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf. Accessed 25 Feb 2015.
    • Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product
  • 5
    • 33644952525 scopus 로고    scopus 로고
    • European Medicines Agency, Accessed 3 Apr 2015
    • European Medicines Agency. Guideline on similar biological medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 3 Apr 2015.
    • Guideline on similar biological medicinal products
  • 7
    • 38549176118 scopus 로고    scopus 로고
    • Tumor necrosis factor antagonist mechanisms of action: a comprehensive review
    • COI: 1:CAS:528:DC%2BD1cXhtV2it74%3D, PID: 18155297
    • Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117(2):244–79.
    • (2008) Pharmacol Ther , vol.117 , Issue.2 , pp. 244-279
    • Tracey, D.1    Klareskog, L.2    Sasso, E.H.3    Salfeld, J.G.4    Tak, P.P.5
  • 8
    • 0033452005 scopus 로고    scopus 로고
    • Regulated commitment of TNF receptor signaling: a molecular switch for death or activation
    • COI: 1:CAS:528:DC%2BD3cXkt1Shtw%3D%3D, PID: 10626900
    • Pimentel-Muinos FX, Seed B. Regulated commitment of TNF receptor signaling: a molecular switch for death or activation. Immunity. 1999;11(6):783–93.
    • (1999) Immunity. , vol.11 , Issue.6 , pp. 783-793
    • Pimentel-Muinos, F.X.1    Seed, B.2
  • 9
    • 43949126520 scopus 로고    scopus 로고
    • Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: comparison among infliximab, etanercept, and adalimumab
    • COI: 1:CAS:528:DC%2BD1cXms1ehurc%3D, PID: 18438840
    • Mitoma H, Horiuchi T, Tsukamoto H, Tamimoto Y, Kimoto Y, Uchino A, et al. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 2008;58(5):1248–57.
    • (2008) Arthritis Rheum. , vol.58 , Issue.5 , pp. 1248-1257
    • Mitoma, H.1    Horiuchi, T.2    Tsukamoto, H.3    Tamimoto, Y.4    Kimoto, Y.5    Uchino, A.6
  • 11
    • 61649087668 scopus 로고    scopus 로고
    • Glycosylation as a strategy to improve antibody-based therapeutics
    • COI: 1:CAS:528:DC%2BD1MXisVShtb0%3D, PID: 19247305
    • Jefferis R. Glycosylation as a strategy to improve antibody-based therapeutics. Nat Rev Drug Discov. 2009;8(3):226–34.
    • (2009) Nat Rev Drug Discov. , vol.8 , Issue.3 , pp. 226-234
    • Jefferis, R.1
  • 13
    • 84904069611 scopus 로고    scopus 로고
    • The challenge of indication extrapolation for infliximab biosimilars
    • COI: 1:CAS:528:DC%2BC2cXhtVaktb%2FM, PID: 24962198
    • Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177–83.
    • (2014) Biologicals. , vol.42 , Issue.4 , pp. 177-183
    • Feagan, B.G.1    Choquette, D.2    Ghosh, S.3    Gladman, D.D.4    Ho, V.5    Meibohm, B.6
  • 14
    • 84911401436 scopus 로고    scopus 로고
    • Biosimilars: the science of extrapolation
    • COI: 1:CAS:528:DC%2BC2cXitVSgs7zK, PID: 25298038
    • Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22):3191–6.
    • (2014) Blood. , vol.124 , Issue.22 , pp. 3191-3196
    • Weise, M.1    Kurki, P.2    Wolff-Holz, E.3    Bielsky, M.C.4    Schneider, C.K.5
  • 15
    • 84897377081 scopus 로고    scopus 로고
    • Biosimilars: in support of extrapolation of indications
    • PID: 24594005
    • Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431–5.
    • (2014) J Crohns Colitis. , vol.8 , Issue.5 , pp. 431-435
    • Ebbers, H.C.1
  • 16
    • 84979713298 scopus 로고    scopus 로고
    • Assessing analytical similarity of proposed Amgen biosimilar ABP 501 to adalimumab
    • Liu J, et al. Assessing analytical similarity of proposed Amgen biosimilar ABP 501 to adalimumab. BioDrugs. doi: 10.1007/s40259-016-0184-3.
    • BioDrugs
    • Liu, J.1
  • 17
    • 59249096762 scopus 로고    scopus 로고
    • Differences in binding and effector functions between classes of TNF antagonists
    • COI: 1:CAS:528:DC%2BD1MXhs1aqu7Y%3D, PID: 19128982
    • Arora T, Padaki R, Liu L, Hamburger AE, Ellison AR, Stevens SR, et al. Differences in binding and effector functions between classes of TNF antagonists. Cytokine. 2009;45(2):124–31.
    • (2009) Cytokine. , vol.45 , Issue.2 , pp. 124-131
    • Arora, T.1    Padaki, R.2    Liu, L.3    Hamburger, A.E.4    Ellison, A.R.5    Stevens, S.R.6
  • 18
    • 77954232611 scopus 로고    scopus 로고
    • Transmembrane TNF-a: structure, function and interaction with anti-TNF agents
    • COI: 1:CAS:528:DC%2BC3cXnvVygt7g%3D, PID: 20194223
    • Horiuchi T, Mitoma H, Harashima S, Tsukamoto H, Shimoda T. Transmembrane TNF-a: structure, function and interaction with anti-TNF agents. Rheumatology. 2010;49(7):1215–28.
    • (2010) Rheumatology. , vol.49 , Issue.7 , pp. 1215-1228
    • Horiuchi, T.1    Mitoma, H.2    Harashima, S.3    Tsukamoto, H.4    Shimoda, T.5
  • 19
    • 84881575765 scopus 로고    scopus 로고
    • Fc receptors: cell activators of antibody functions
    • Rosales C, Uribe-Querol E. Fc receptors: cell activators of antibody functions. Adv Biosci Biotechnol. 2013;4:21–33.
    • (2013) Adv Biosci Biotechnol. , vol.4 , pp. 21-33
    • Rosales, C.1    Uribe-Querol, E.2
  • 20
  • 21
    • 34248578489 scopus 로고    scopus 로고
    • Binding characteristics of tumor necrosis factor receptor-Fc fusion proteins vs anti-tumor necrosis factor mAbs
    • COI: 1:CAS:528:DC%2BD2sXlt1aqsbY%3D
    • Kohno T, Tam LT, Stevens SR, Louie JS. Binding characteristics of tumor necrosis factor receptor-Fc fusion proteins vs anti-tumor necrosis factor mAbs. J Invest Dermatol Symp Proc. 2007;12(1):5–8.
    • (2007) J Invest Dermatol Symp Proc. , vol.12 , Issue.1 , pp. 5-8
    • Kohno, T.1    Tam, L.T.2    Stevens, S.R.3    Louie, J.S.4
  • 22
    • 0035894504 scopus 로고    scopus 로고
    • Characterization of noncovalent complexes of recombinant human monoclonal antibody and antigen using cation exchange, size exclusion chromatography, and BIAcore
    • COI: 1:CAS:528:DC%2BD3MXoslSktbY%3D, PID: 11730333
    • Santora LC, Kaymakcalan Z, Sakorafas P, Krull IS, Grant K. Characterization of noncovalent complexes of recombinant human monoclonal antibody and antigen using cation exchange, size exclusion chromatography, and BIAcore. Analyt Biochem. 2001;299(2):119–29.
    • (2001) Analyt Biochem. , vol.299 , Issue.2 , pp. 119-129
    • Santora, L.C.1    Kaymakcalan, Z.2    Sakorafas, P.3    Krull, I.S.4    Grant, K.5
  • 23
    • 36749070996 scopus 로고    scopus 로고
    • Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents
    • PID: 17636564
    • Nesbitt A, Fossati G, Bergin M, Stephens P, Stephens S, Foulkes R, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13(11):1323–32.
    • (2007) Inflamm Bowel Dis. , vol.13 , Issue.11 , pp. 1323-1332
    • Nesbitt, A.1    Fossati, G.2    Bergin, M.3    Stephens, P.4    Stephens, S.5    Foulkes, R.6
  • 24
    • 84901497185 scopus 로고    scopus 로고
    • Systematic review with network meta-analysis: the efficacy of anti-TNF agents for the treatment of Crohn’s disease
    • COI: 1:CAS:528:DC%2BC2cXos1WlurY%3D, PID: 24749763
    • Stidham RW, Lee TC, Higgins PD, Deshpande AR, Sussman DA, Singal AG, et al. Systematic review with network meta-analysis: the efficacy of anti-TNF agents for the treatment of Crohn’s disease. Aliment Pharmacol Ther. 2014;39(12):1349–62.
    • (2014) Aliment Pharmacol Ther. , vol.39 , Issue.12 , pp. 1349-1362
    • Stidham, R.W.1    Lee, T.C.2    Higgins, P.D.3    Deshpande, A.R.4    Sussman, D.A.5    Singal, A.G.6
  • 25
    • 84921325308 scopus 로고    scopus 로고
    • Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn’s disease: a network meta-analysis
    • COI: 1:CAS:528:DC%2BC2MXhsVeis78%3D, PID: 25448924
    • Hazlewood GS, Rezaie A, Borman M, Panaccione R, Ghosh S, Seow CH, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn’s disease: a network meta-analysis. Gastroenterology. 2015;148(2):344–54.
    • (2015) Gastroenterology. , vol.148 , Issue.2 , pp. 344-354
    • Hazlewood, G.S.1    Rezaie, A.2    Borman, M.3    Panaccione, R.4    Ghosh, S.5    Seow, C.H.6
  • 26
    • 84980688391 scopus 로고    scopus 로고
    • Pharmacokinetic equivalence of ABP 501 relative to adalimumab: results from a randomized, single-blind, single-dose, parallel group study in healthy subjects [abstract]
    • Kaur PP, Chow V, Zhang N, Moxness M, Markus R. Pharmacokinetic equivalence of ABP 501 relative to adalimumab: results from a randomized, single-blind, single-dose, parallel group study in healthy subjects [abstract]. Arthritis Rheumatol. 2014;66(10 Suppl.):S661–2.
    • (2014) Arthritis Rheumatol. , vol.66 , pp. S661-S662
    • Kaur, P.P.1    Chow, V.2    Zhang, N.3    Moxness, M.4    Markus, R.5
  • 27
    • 84969438210 scopus 로고    scopus 로고
    • A randomized, single-blind, single-dose, parallel group study in healthy subjects to demonstrate pharmacokinetic equivalence of biosimilar candidate ABP 501 and adalimumab (EU) [abstract]
    • Kaur P, Chow V, Zhang N, Moxness M, Markus R. A randomized, single-blind, single-dose, parallel group study in healthy subjects to demonstrate pharmacokinetic equivalence of biosimilar candidate ABP 501 and adalimumab (EU) [abstract]. Ann Rheum Dis. 2014;73(Suppl. 2):479.
    • (2014) Ann Rheum Dis. , vol.73 , pp. 479
    • Kaur, P.1    Chow, V.2    Zhang, N.3    Moxness, M.4    Markus, R.5
  • 29
    • 84980688310 scopus 로고    scopus 로고
    • Strober B, Armstrong A, Gordon K, Gottlieb A, Greenberg JD, Koo J, et al. Evaluation of efficacy and safety of ABP 501 in a phase 3 study in subjects with moderate to severe plaque psoriasis: 52-week results, March 4–8, Washington DC
    • Strober B, Armstrong A, Gordon K, Gottlieb A, Greenberg JD, Koo J, et al. Evaluation of efficacy and safety of ABP 501 in a phase 3 study in subjects with moderate to severe plaque psoriasis: 52-week results. American Academy of Dermatology, March 4–8, 2016, Washington DC.
    • (2016) American Academy of Dermatology
  • 30
    • 84953377504 scopus 로고    scopus 로고
    • Randomized, double-blind, phase 3 study of efficacy and safety of ABP 501 compared with adalimumab in subjects with moderate to severe rheumatoid arthritis [abstract]
    • Cohen SB, Genovese MC, Choy EH, Perez-Ruiz F, Pablos JL, Zhang N, et al. Randomized, double-blind, phase 3 study of efficacy and safety of ABP 501 compared with adalimumab in subjects with moderate to severe rheumatoid arthritis [abstract]. Arthritis Rheumatol. 2015;67(Suppl. 10):2054.
    • (2015) Arthritis Rheumatol. , vol.67 , pp. 2054
    • Cohen, S.B.1    Genovese, M.C.2    Choy, E.H.3    Perez-Ruiz, F.4    Pablos, J.L.5    Zhang, N.6
  • 31
    • 85035200163 scopus 로고    scopus 로고
    • Secondary efficacy endpoints: sesults from a phase 3 study comparing ABP 501 with adalimumab in subjects with moderate to severe rheumatoid arthritis [abstract]
    • Matsumoto AK, Pavelka K, Rizzo W, Gupta R, Shergy W, Haycaj P, et al. Secondary efficacy endpoints: sesults from a phase 3 study comparing ABP 501 with adalimumab in subjects with moderate to severe rheumatoid arthritis [abstract]. Arthritis Rheumatol. 2015;67(Suppl. 10):2757.
    • (2015) Arthritis Rheumatol. , vol.67 , pp. 2757
    • Matsumoto, A.K.1    Pavelka, K.2    Rizzo, W.3    Gupta, R.4    Shergy, W.5    Haycaj, P.6
  • 32
    • 84948714665 scopus 로고    scopus 로고
    • Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197
    • COI: 1:CAS:528:DC%2BC28Xpslehu7g%3D
    • Bandyopadhyay S, Mahajan M, Mehta T, Singh AK, Parikh A, Gupta AK. Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197. Biosimilars. 2015;5:1–18.
    • (2015) Biosimilars. , vol.5 , pp. 1-18
    • Bandyopadhyay, S.1    Mahajan, M.2    Mehta, T.3    Singh, A.K.4    Parikh, A.5    Gupta, A.K.6


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