Literature DB >> 26077557

IBD: Indication extrapolation for anti-TNF biosimilars.

Niels Vande Casteele1, William J Sandborn1.   

Abstract

Biosimilar monoclonal antibodies (mAbs) to TNF are being developed that are highly similar, but not identical to the innovator molecules. CT-P13, a biosimilar of infliximab, is the first anti-TNF mAb to get approval in South Korea, Europe and Canada. However, uncertainties remain about indication extrapolation and interchangeability.

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Year:  2015        PMID： 26077557     DOI： 10.1038/nrgastro.2015.104

Source DB:  PubMed          Journal:  Nat Rev Gastroenterol Hepatol        ISSN： 1759-5045            Impact factor:   46.802


  10 in total

1.  Population pharmacokinetics of infliximab in patients with ankylosing spondylitis.

Authors:  Zhenhua Xu; Kathleen Seitz; Adedigbo Fasanmade; Joyce Ford; Paul Williamson; Weichun Xu; Hugh M Davis; Honghui Zhou
Journal:  J Clin Pharmacol       Date:  2008-04-09       Impact factor: 3.126

2.  Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis.

Authors:  Adedigbo A Fasanmade; Omoniyi J Adedokun; Joyce Ford; Danika Hernandez; Jewel Johanns; Chuanpu Hu; Hugh M Davis; Honghui Zhou
Journal:  Eur J Clin Pharmacol       Date:  2009-09-16       Impact factor: 2.953

3.  Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima.

Authors:  Shomron Ben-Horin; Miri Yavzori; Itai Benhar; Ella Fudim; Orit Picard; Bella Ungar; SooYoung Lee; SungHwan Kim; Rami Eliakim; Yehuda Chowers
Journal:  Gut       Date:  2015-04-20       Impact factor: 23.059

Review 4.  IgG Fc receptors.

Authors:  J V Ravetch; S Bolland
Journal:  Annu Rev Immunol       Date:  2001       Impact factor: 28.527

Review 5.  The challenge of indication extrapolation for infliximab biosimilars.

Authors:  Brian G Feagan; Denis Choquette; Subrata Ghosh; Dafna D Gladman; Vincent Ho; Bernd Meibohm; Guangyong Zou; Zhenhua Xu; Gopi Shankar; David C Sealey; Anthony S Russell
Journal:  Biologicals       Date:  2014-06-21       Impact factor: 1.856

6.  Adalimumab induces apoptosis of human monocytes: a comparative study with infliximab and etanercept.

Authors:  C Shen; G V Assche; S Colpaert; P Maerten; K Geboes; P Rutgeerts; J L Ceuppens
Journal:  Aliment Pharmacol Ther       Date:  2005-02-01       Impact factor: 8.171

Review 7.  Neonatal Fc receptor: from immunity to therapeutics.

Authors:  Timothy T Kuo; Kristi Baker; Masaru Yoshida; Shuo-Wang Qiao; Victoria G Aveson; Wayne I Lencer; Richard S Blumberg
Journal:  J Clin Immunol       Date:  2010-10-01       Impact factor: 8.317

8.  Infliximab but not etanercept induces apoptosis in lamina propria T-lymphocytes from patients with Crohn's disease.

Authors:  Jan M H Van den Brande; Henri Braat; Gijs R van den Brink; Henri H Versteeg; Christiaan A Bauer; Inge Hoedemaeker; Catherine van Montfrans; Daan W Hommes; Maikel P Peppelenbosch; Sander J H van Deventer
Journal:  Gastroenterology       Date:  2003-06       Impact factor: 22.682

9.  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.

Authors:  Dae Hyun Yoo; Pawel Hrycaj; Pedro Miranda; Edgar Ramiterre; Mariusz Piotrowski; Sergii Shevchuk; Volodymyr Kovalenko; Nenad Prodanovic; Mauricio Abello-Banfi; Sergio Gutierrez-Ureña; Luis Morales-Olazabal; Michael Tee; Renato Jimenez; Omid Zamani; Sang Joon Lee; HoUng Kim; Won Park; Ulf Müller-Ladner
Journal:  Ann Rheum Dis       Date:  2013-05-16       Impact factor: 19.103

10.  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.

Authors:  Won Park; Pawel Hrycaj; Slawomir Jeka; Volodymyr Kovalenko; Grygorii Lysenko; Pedro Miranda; Helena Mikazane; Sergio Gutierrez-Ureña; MieJin Lim; Yeon-Ah Lee; Sang Joon Lee; HoUng Kim; Dae Hyun Yoo; Jürgen Braun
Journal:  Ann Rheum Dis       Date:  2013-05-16       Impact factor: 19.103
  10 in total
  6 in total

Review 1.  Biosimilars in IBD: from theory to practice.

Authors:  Silvio Danese; Stefanos Bonovas; Laurent Peyrin-Biroulet
Journal:  Nat Rev Gastroenterol Hepatol       Date:  2016-10-12       Impact factor: 46.802

Review 2.  Biosimilars in Pediatric IBD: Updated Considerations for Disease Management.

Authors:  Valeria Dipasquale; Ugo Cucinotta; Claudio Romano
Journal:  Biologics       Date:  2022-06-13

Review 3.  How Will Evolving Future Therapies and Strategies Change How We Position the Use of Biologics in Moderate to Severely Active Inflammatory Bowel Disease.

Authors:  Parambir S Dulai; Siddharth Singh; Niels V Casteele; Brigid S Boland; William J Sandborn
Journal:  Inflamm Bowel Dis       Date:  2016-04       Impact factor: 5.325

Review 4.  Biosimilars and the extrapolation of indications for inflammatory conditions.

Authors:  John Rp Tesser; Daniel E Furst; Ira Jacobs
Journal:  Biologics       Date:  2017-02-17

5.  Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product.

Authors:  Ramsey Saleem; Greg Cantin; Mats Wikström; Glen Bolton; Scott Kuhns; Helen J McBride; Jennifer Liu
Journal:  Pharm Res       Date:  2020-05-31       Impact factor: 4.200

6.  Biosimilars in Pediatric Inflammatory Bowel Diseases: A Systematic Review and Real Life-Based Evidence.

Authors:  Valeria Dipasquale; Giuseppe Cicala; Edoardo Spina; Claudio Romano
Journal:  Front Pharmacol       Date:  2022-03-17       Impact factor: 5.810
  6 in total

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