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Review

A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®)

, & ORCID Icon
Pages 2831-2840 | Published online: 17 Jul 2020

References

  • YooDH, HrycajP, MirandaP, 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(10):1613. doi:10.1136/annrheumdis-2012-20309023687260
  • Celltrion. CT-P13 briefing document for the arthritis advisory committee. [updated 29, 2016; cited 2, 2016]. Available from: https://www.fda.gov/media/95998/download.
  • Food and Drug Administration. Statistical review of BLA125544. [cited 10, 2015]. Available from: www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000StatR.pdf. Accessed 57, 2020.
  • CohenSB, AltenR, KamedaH, et al. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. Arthritis Res Ther. 2018;20(1):155. doi:10.1186/s13075-018-1646-430053896
  • Food and Drug Administration. Biosimilar multi-disciplinary evaluation and review: BLA 761086 ABP 710, a proposed biosimilar to U.S.-licensed remicade (infliximab). [cited 12, 2018]. Available from: https://www.fda.gov/media/134460/download. Accessed 57, 2020.
  • LeeH. Equivalence margin of the biosimilar product. J Korean Soc Clin Pharmacol Ther. 2012;20(1):17–33. doi:10.12793/jkscpt.2012.20.1.17
  • Food and Drug Administration. Guidance for industry: non-inferiority clinical trials to establish effectiveness. [cited 11, 2016]. Available from: https://www.fda.gov/media/78504/download. Accessed 57, 2020.
  • NjueC. Statistical considerations for confirmatory clinical trials for similar biotherapeutic products. Biologicals. 2011;39(5):266–269. doi:10.1016/j.biologicals.2011.06.00621807534
  • HwangIK, MorikawaT. Design issues in noninferiority/equivalence trials. Drug Inf J. 1999;33(4):1205–1218. doi:10.1177/009286159903300424
  • LaunoisR, AvouacB, BerenbaumF, et al. Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment bayesian metaanalysis. J Rheumatol. 2011;38(5):835–845. doi:10.3899/jrheum.10066521239748
  • AaltonenKJ, VirkkiLM, MalmivaaraA, KonttinenYT, NordstromDC, BlomM. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275. doi:10.1371/journal.pone.003027522272322
  • WesthovensR, YocumD, HanJ, et al. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial. Arthritis Rheum. 2006;54(4):1075–1086. doi:10.1002/art.2173416572442
  • AbeT, TakeuchiT, MiyasakaN, et al. A multicenter, double-blind, randomized, placebo controlled trial of infliximab combined with low dose methotrexate in Japanese patients with rheumatoid arthritis. J Rheumatol. 2006;33(1):37–44.16395748
  • ZhangFC, HouY, HuangF, et al. Infliximab versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a preliminary study from China. APLAR J Rheum Dis. 2006;9(2):127–130. doi:10.1111/j.1479-8077.2006.00186.x
  • R Foundation for Statistical Computing. R: a language and environment for statistical computing. [cited 2018]. Available from: https://www.R-project.org.
  • DerSimonianR, LairdN. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177–188. doi:10.1016/0197-2456(86)90046-23802833
  • MainiR, St ClairEW, BreedveldF, et al. Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised Phase III trial. Lancet. 1999;354(9194):1932–1939. doi:10.1016/S0140-6736(99)05246-010622295
  • SchiffM, KeisermanM, CoddingC, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a Phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008;67(8):1096–1103. doi:10.1136/ard.2007.08000218055472
  • Food and Drug Administration. FDA briefing information for the february 9, 2016 meeting of the arthritis advisory committee. [cited 29, 2016]. Available from: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM484859.pdf. Accessed 57, 2020.
  • KamedaH, FujiiT, NakajimaA, et al. Japan college of rheumatology guideline for the use of methotrexate in patients with rheumatoid arthritis. Mod Rheumatol. 2019;29(1):31–40. doi:10.1080/14397595.2018.147235829718746
  • GenoveseMC, CovarrubiasA, LeonG, et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011;63(10):2854–2864. doi:10.1002/art.3046321618201
  • ICH Expert Working Group. ICH harmonised tripartite guideline, E9: statistical principles for clinical trials. [cited 1998]. Available from: https://database.ich.org/sites/default/files/E9_Guideline.pdf. Accessed 513, 2020.