279
guidancecomplianceregulatoryinformation/guidances/ucm397017.pdf.Last Updated May
2014.
- Food & Drug Administration. Guidance for industry quality systems approach to pharmaceuti-
cal CGMP regulations. http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070337.pdf. - Food & Drug Administration. Scientific considerations in demonstrating biosimi-
larity to a reference product guidance for industry. http://www.fda.gov/downloads/
DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. - Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima. MAbs.
2014;6:1163–77. - FDA Briefing Document: Arthritis Advisory Committee Meeting February 09, 2016. http://
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/
ArthritisAdvisoryCommittee/UCM484859.pdf. Updated on 02 Nov 2016. - Park W, Lee SJ, Yun J, et al. Comparison of the pharmacokinetics and safety of three formula-
tions of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference
infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-
dose, Phase I study. Expert Rev. Clin Immunol. 2015;11(Suppl 1):25–31. - Isaacs JD, Cutolo M, Keystone EC, et al. Biosimilars in immune-mediated inflammatory dis-
eases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal
antibody. J Intern Med. 2015;279(1):41–59. - Rudwaleit M, Baeten D. Ankylosing spondylitis and bowel disease. Best Pract Res Clin
Rheumatol. 2006;20:451–71. - Park W, Jaworski J, Brzezicki J, et al. A randomized, double-blind, parallel-group, phase
1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in
patients with active ankylosing sponylitis: 54 week results from the PLANETAS Study. Ann
Rheum Dis. 2013;72:516. - Park W, Miranda P, Brzosko B, et al. Efficacy and safety of CT-P13 (infliximab biosimilar)
over two years in patients with ankylosing spondylitis: comparison between continuing with
CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum. 2013;65:3326. - Yoo DH, Racewicz A, Brzezicki J, et al. A phase 3 randomized controlled trial to compare
CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the
PLANETRA study. Ann Rheum Dis. 2013;72:73. - Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (infliximab biosimilar)
over two years in patients with rheumatoid arthritis: comparison between continued CT-P13
and switching from infliximab to CT-P13. Arthritis Rheum. 2013;65:3319. - Papamichael K, Van Stappen T, Jairath V, et al. Review article: pharmacological aspects
of anti- TNF biosimilars in inflammatory bowel diseases. Aliment Pharmacol Ther.
2015;42:1158–69. - Jahnsen J, Detlie TE, Vatn S, et al. Biosimilar infliximab (CT-P13) in the treatment of inflam-
matory bowel disease: a Norwegian observational study. Expert Rev. Gastroenterol Hepatol.
2015;9(Suppl 1):45–52. - Gecse KB, Lovasz BD, Farkas K, et al. Efficacy and safety of the biosimilar infliximab CT-P13
treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort.
J Crohns Colitis. 2016;10:133–40. - Ordas I, Feagan BG, Sandborn WJ. Therapeutic drug monitoring of tumor necrosis factor
antagonists in inflammatory bowel disease. Clin Gastroenterol Hepatol. 2012;10:1079–87.
quiz e85-6 - Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy
of infliximab in Crohn’s Disease. N Engl J Med. 2003;348:601–8. - 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. - Lipsky PE, van der Heijde DM, St Clair EW, et al. Infliximab and methotrexate in the treat-
ment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with con-
comitant therapy study group. N Engl J Med. 2000;343:1594–602.
15 Biosimilars in Inflammatory Bowel Disease 2017: State of the Science