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Biosimilar monoclonal antibodies: the scientific basis for extrapolation

, MD PhD (Professor) , , MA JD (Associate Professor) , , MD & , PhD

Bibliography

  • U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for industry scientific considerations in demonstrating biosimilarity to a reference product. Rockville, MD: 2012
  • European Medicines Agency. Guideline on similar biological medicinal products (Revision). CHMP/437/04 Rev 1 London, UK: 2014
  • Health Canada. Guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs). Ottawa, ON, Canada: 2010
  • Therapeutic Goods Administration. Evaluation of biosimilars. Woden ACT, Australia: 2013
  • World Health Organization Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva, Switzerland: 2009
  • Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014;16:22-6
  • 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
  • European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. London, UK: 2012
  • U.S. Department of Health and Human Services, Food and Drug Administration. FDA approves first biosimilar product Zarxio. 2015. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm [Last accessed 16 March 2015]
  • 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
  • Genazzani AA, Biggio G, Caputi AP, et al. Biosimilar drugs: concerns and opportunities. BioDrugs 2007;21:351-6
  • Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin 2012;28:1053-8
  • 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
  • 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
  • Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia “epidemic”–mystery completely revealed? Perit Dial Int 2007;27:S303-7
  • European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005 London, UK: 2006
  • European Medicines Agency. Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor. EMEA/CHMP/BMWP/31329/2005 London, UK: 2006
  • European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision). EMEA/CHMP/BMWP/301636/2008 Corr London, UK: 2010
  • Feagan BG, Choquette D, Ghosh S, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 2014;42:177-83
  • European Medicines Agency. 2015. Available from: http://www.ema.europa.eu/ema/ [Last accessed 9 June 2015]
  • Miletich J, Eich G, Grampp G, Mounho B. Biosimilars 2.0: guiding principles for a global “patients first” standard. mAbs 2011;3:318-25
  • European Medicines Agency. EPAR summary for the public: Inflectra. EMA/402688/2013 London, UK: 2013
  • Remicade® (infliximab). Full Prescribing Information. Janssen Biotech, Inc; Horsham, PA: 2013
  • 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
  • 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
  • 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]
  • 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
  • European Medicines Agency. Assessment report: Remsima. EMA/CHMP/589317/2013 London, UK: 2013
  • U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for industry Q8(R2) pharmaceutical development. Rockville, MD: 2009
  • Rathore AS, Reason AJ, Weiskopf A. Defining critical quality attributes for monoclonal antibody therapeutic products. BioPharm International 2014;27:34-43
  • Shi S. Biologics: an update and challenge of their pharmacokinetics. Curr Drug Metab 2014;15:271-90
  • Sola RJ, Griebenow K. Glycosylation of therapeutic proteins: an effective strategy to optimize efficacy. BioDrugs 2010;24:9-21
  • Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 2013;72:1589-93
  • 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
  • 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
  • Humira® (adalimumab). Full Prescribing Information. AbbVie Inc.; North Chicago, IL: 2013
  • Wolbink GJ, Aarden LA, Dijkmans BA. Dealing with immunogenicity of biologicals: assessment and clinical relevance. Curr Opin Rheumatol 2009;21:211-15
  • Jmol: an open-source Java viewer for chemical structures in 3D. Available from: http://jmol.sourceforge.net/ [Last accessed 9 June 2015]
  • 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
  • Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 2002;359:1541-9
  • 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
  • Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn’s disease. N Engl J Med 2004;350:876-85
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

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