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Immunology

The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar

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Pages 993-1003 | Received 29 Nov 2016, Accepted 26 Jan 2017, Published online: 07 Feb 2017

References

  • Kuek A, Hazleman BL, Ostor AJ. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J 2007;83:251-60
  • Stryjewska A, Kiepura K, Librowski T, et al. Biotechnology and genetic engineering in the new drug development. Part I. DNA technology and recombinant proteins. Pharmacol Rep 2013;65:1075-85
  • Morrow T, Felcone LH. Defining the difference: what makes biologics unique. Biotechnol Healthc 2004;1:24-9
  • Weise M, Bielsky MC, De Smet K, et al. Biosimilars – why terminology matters. Nat Biotechnol 2011;29:690-3
  • Endrenyi L, Jamali F, Loebenberg R. Subsequent entry biologics in Canada: current state of the science. J Pharm Pharm Sci 2015;18:177-83
  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Food and Drug Administration Guidance for Industry (FDA). 2015. Available at: http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf [Last accessed October 2016]
  • Olech E. Biosimilars: rationale and current regulatory landscape. Semin Arthritis Rheum 2016;45(Suppl 5):S1-S10
  • Dörner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol 2015;11:713-24
  • Eleryan MG, Akhiyat S, Rengifo-Pardo M, Ehrlich A. Biosimilars: potential implications for clinicians. Clin Cosmet Investig Dermatol 2016;9:135-42
  • Nikolov NP, Shapiro MA. An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology. Nat Rev Rheumatol 2017: published online 5 January 2017, doi: 10.1038/nrrheum.2016.204
  • Molinelli E, Campanati A, Ganzetti G, et al. Biologic therapy in immune mediated inflammatory disease: basic science and clinical concepts. Curr Drug Saf 2016;11:35-43
  • American College Rheumatology Position Statement on Patient Access to Biologics. Available at: http://www.rheumatology.org/Portals/0/Files/Patient%20Access%20to%20Biologics%20aka%20Model%20Biologics.pdf [Last accessed October 2016]
  • Isaacs JD, Cutolo M, Keystone EC, et al. 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
  • Buffery D. Competition from biosimilars an incentive for innovation. Am Health Drug Benefits 2010;3:27-8
  • Strand V, Cronstein B. Biosimilars: how similar? Intern Med J 2014;44:218-23
  • Stanhope R, Sorgel F, Gravel P, et al. Bioequivalence studies of Omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis. J Clin Pharmacol 2010;50:1339-48
  • Khraishi M, Stead D, Lukas M, et al. Biosimilars: a multidisciplinary perspective. Clin Ther 2016;38:1238-49
  • Dorner T, Strand V, Cornes P, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis 2016;75:974-82
  • Holzmann J, Balser S, Windisch J. Totality of the evidence at work: The first U.S. biosimilar. Expert Opin Biol Ther 2016;16:137-42
  • McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012;91:405-17
  • Strober BE, Armour K, Romiti R, et al. Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know. J Am Acad Dermatol 2012;66:317-22
  • Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310-12
  • Rupprechter A, Fuchs M, Lamanna W, et al., inventors. Sandoz AG, assignee. Quantification of misfolded tnfr2:fc. World Intellectual Property Organization patent WO2016009036 A1. 21 January 2016
  • 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
  • Guideline on similar biological medicinal products. European Medicines Agency (EMA), 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf [Last accessed October 2016]
  • 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(Suppl 1):17-26
  • Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation. Blood 2014;124:3191-6
  • Gerrard TL, Johnston G, Gaugh DR. Biosimilars: extrapolation of clinical use to other indications. GaBi J 2015;4:118-24
  • Scott LJ. Etanercept: a review of its use in autoimmune inflammatory diseases. Drugs 2014;74:1379-410
  • Haraoui B, Bykerk V. Etanercept in the treatment of rheumatoid arthritis. Ther Clin Risk Manag 2007;3:99-105
  • Tracey D, Klareskog L, Sasso EH, et al. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008;117:244-79
  • Moreland LW, Schiff MH, Baumgartner SW, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 1999;130:478-86
  • Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;340:253-9
  • Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93
  • Klareskog L, van der Heijde D, de Jager JP, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004;363:675-81
  • Lovell DJ, Giannini EH, Reiff A, et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med 2000;342:763-9
  • Davis JC Jr, Van Der Heijde D, Braun J, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum 2003;48:3230-6
  • Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol 2006;33:712-21
  • Mease PJ, Kivitz AJ, Burch FX, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum 2004;50:2264-72
  • Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003;349:2014-22
  • Papp KA, Tyring S, Lahfa M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol 2005;152:1304-12
  • Tyring S, Gordon KB, Poulin Y, et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol 2007;143:719-26
  • Paller AS, Siegfried EC, Langley RG, et al. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med 2008;358:241-51
  • Sedger LM, McDermott MF. TNF and TNF-receptors: From mediators of cell death and inflammation to therapeutic giants – past, present and future. Cytokine Growth Factor Rev 2014;25:453-72
  • Lemos LL, de Oliveira Costa J, Almeida AM, et al. Treatment of psoriatic arthritis with anti-TNF agents: a systematic review and meta-analysis of efficacy, effectiveness and safety. Rheumatol Int 2014;34:1345-60
  • Girolomoni G, Altomare G, Ayala F, et al. Safety of anti-TNFalpha agents in the treatment of psoriasis and psoriatic arthritis. Immunopharmacol Immunotoxicol 2012;34:548-60
  • Prinz JC, Puig L, Girolomoni G. Treatment of psoriasis with etanercept: the typical patient profile. J Eur Acad Dermatol Venereol 2016;30:1092-9
  • Hofmann HP, Kronthaler U, Fritsch C, et al. Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel). Expert Opin Biol Ther 2016;16:1185-95
  • Dhillon S, Lyseng-Williamson KA, Scott LJ. Etanercept: a review of its use in the management of rheumatoid arthritis. Drugs 2007;67:1211-41
  • Campa M, Ryan C, Menter A. An overview of developing TNF-α targeted therapy for the treatment of psoriasis. Expert Opin Investig Drugs 2015;24:1343-54
  • 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;93:315-17
  • Afonso M, Sanguino Heinrich S, Poetzl J, et al. Pharmacokinetics and safety of GP2015, a proposed etanercept biosimilar, and etanercept originator product in healthy male subjects: a randomised two-way crossover study. Ann Rheum Dis 2016;75(Suppl 2):234
  • von Richter O, Skerjanec A, Afonso M, et al. GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its auto-injector device with pre-filled syringes. Br J Clin Pharmacol 2016: published online 27 October 2016, doi: 10.1111/bcp.13170
  • Afonso M, Kollins D, Macke L, et al. Pharmacokinetics and safety of GP2015, a proposed etanercept biosimilar, administered subcutaneously by an autoinjector or prefilled syringe in healthy male subjects. Ann Rheum Dis 2016;75(Suppl 2):233
  • Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis 2005;64(Suppl 2):ii65-8; discussion ii69-73
  • Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014;16:22-6
  • Griffiths CE, Thaçi D, Gerdes S, et al. The EGALITY study: a confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis. Br J Dermatol 2016: published online 27 October 2016: doi: 10.1111/bjd.15152
  • Strober B, Foley P, Philipp S, 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. J Am Acad Dermatol 2016;74(Suppl 5):AB249

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