Literature DB >> 31435122

Biosimilars for the Treatment of Inflammatory Bowel Disease.

Vivek A Rudrapatna1, Fernando Velayos2.   

Abstract

Biosimilars are biologic products that are highly similar to a previously approved reference (or originator) biologic drug in terms of safety, purity, and potency (efficacy). These medications are increasingly being approved by global regulatory agencies in the hopes of reducing treatment costs. To date, six biosimilars in the United States have been approved for the treatment of inflammatory bowel disease (IBD). Despite their approval by regulatory bodies and several years-worth of 'real world' evidence supporting their use, this class of medications remain somewhat unfamiliar to many clinicians and patients. This review aims to answer common questions regarding biosimilars and their use for IBD. It is written in a question/answer format for easy reference and guides the reader from the basics of biosimilars, to clinically relevant questions encountered in the clinic, to their policy implications, among other topics.

Entities:  

Year:  2019        PMID: 31435122      PMCID: PMC6703165     

Source DB:  PubMed          Journal:  Pract Gastroenterol        ISSN: 0277-4208


  18 in total

Review 1.  Systematic review with meta-analysis: the efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-α agent (infliximab), in inflammatory bowel diseases.

Authors:  Y Komaki; A Yamada; F Komaki; D Micic; A Ido; A Sakuraba
Journal:  Aliment Pharmacol Ther       Date:  2017-02-26       Impact factor: 8.171

2.  ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease-An Update.

Authors:  Silvio Danese; Gionata Fiorino; Tim Raine; Marc Ferrante; Karen Kemp; Jaroslaw Kierkus; Peter L Lakatos; Gerassimos Mantzaris; Janneke van der Woude; Julian Panes; Laurent Peyrin-Biroulet
Journal:  J Crohns Colitis       Date:  2016-12-07       Impact factor: 9.071

3.  Switching from originator to biosimilar infliximab - real world data of a prospective 18 months follow-up of a single-centre IBD population.

Authors:  Marte L Høivik; Lydia C T Buer; Milada Cvancarova; David J Warren; Nils Bolstad; Bjørn A Moum; Asle W Medhus
Journal:  Scand J Gastroenterol       Date:  2018-05-31       Impact factor: 2.423

4.  Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial.

Authors:  Kristin K Jørgensen; Inge C Olsen; Guro L Goll; Merete Lorentzen; Nils Bolstad; Espen A Haavardsholm; Knut E A Lundin; Cato Mørk; Jørgen Jahnsen; Tore K Kvien
Journal:  Lancet       Date:  2017-05-11       Impact factor: 79.321

5.  Drug Survival and Immunogenicity After Switching From Remicade to Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: Two-year Follow-up of a Prospective Observational Cohort Study.

Authors:  Lisa J T Smits; Aura A J van Esch; Lauranne A A P Derikx; Ronald Boshuizen; Dirk J de Jong; Joost P H Drenth; Frank Hoentjen
Journal:  Inflamm Bowel Dis       Date:  2019-01-01       Impact factor: 5.325

6.  The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar.

Authors:  Gionata Fiorino; Natalia Manetti; Alessandro Armuzzi; Ambrogio Orlando; Angela Variola; Stefanos Bonovas; Fabrizio Bossa; Giovanni Maconi; Renata DʼIncà; Paolo Lionetti; Laura Cantoro; Walter Fries; Maria L Annunziata; Francesco Costa; Maria M Terpin; Livia Biancone; Claudio C Cortelezzi; Arnaldo Amato; Sandro Ardizzone; Silvio Danese; Luisa Guidi; Giulia Rizzuto; Arianna Massella; Angelo Andriulli; Alessandro Massari; Greta Lorenzon; Silvia Ghione; Anna Kohn; Agostino Ventra; Vito Annese
Journal:  Inflamm Bowel Dis       Date:  2017-02       Impact factor: 5.325

7.  Efficacy and tolerability of initiating, or switching to, infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD): a large single-centre experience.

Authors:  Raguprakash Ratnakumaran; Natalie To; David J Gracie; Christian P Selinger; Anthony O'Connor; Tanya Clark; Nicola Carey; Katherine Leigh; Lynsey Bourner; Alexander C Ford; P John Hamlin
Journal:  Scand J Gastroenterol       Date:  2018-04-24       Impact factor: 2.423

8.  Long-Term Clinical Outcomes After Switching from Remicade® to Biosimilar CT-P13 in Inflammatory Bowel Disease.

Authors:  Lisa J T Smits; Anna Grelack; Lauranne A A P Derikx; Dirk J de Jong; Aura A J van Esch; Ronald S Boshuizen; Joost P H Drenth; Frank Hoentjen
Journal:  Dig Dis Sci       Date:  2017-06-30       Impact factor: 3.199

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

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  7 in total

Review 1.  Opportunities and challenges in using real-world data for health care.

Authors:  Vivek A Rudrapatna; Atul J Butte
Journal:  J Clin Invest       Date:  2020-02-03       Impact factor: 14.808

Review 2.  Inflammatory Bowel Disease Treatments and Predictive Biomarkers of Therapeutic Response.

Authors:  Duaa Ahmed Elhag; Manoj Kumar; Marwa Saadaoui; Anthony K Akobeng; Fatma Al-Mudahka; Mamoun Elawad; Souhaila Al Khodor
Journal:  Int J Mol Sci       Date:  2022-06-23       Impact factor: 6.208

Review 3.  Emerging role of biosimilars in the clinical care of inflammatory bowel disease patients.

Authors:  Hala Najeeb; Farah Yasmin; Salim Surani
Journal:  World J Clin Cases       Date:  2022-05-16       Impact factor: 1.534

4.  Relapse From Deep Remission After Therapeutic De-escalation in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis.

Authors:  Bing Zhang; Alakh Gulati; Omeed Alipour; Ling Shao
Journal:  J Crohns Colitis       Date:  2020-10-05       Impact factor: 9.071

Review 5.  Revisiting Inflammatory Bowel Disease: Pathology, Treatments, Challenges and Emerging Therapeutics Including Drug Leads from Natural Products.

Authors:  Karma Yeshi; Roland Ruscher; Luke Hunter; Norelle L Daly; Alex Loukas; Phurpa Wangchuk
Journal:  J Clin Med       Date:  2020-04-28       Impact factor: 4.241

6.  Clinical Practice of Adalimumab and Infliximab Biosimilar Treatment in Adult Patients With Crohn's Disease.

Authors:  Walter Reinisch; Krisztina Gecse; Jonas Halfvarson; Peter M Irving; Jørgen Jahnsen; Laurent Peyrin-Biroulet; Gerhard Rogler; Stefan Schreiber; Silvio Danese
Journal:  Inflamm Bowel Dis       Date:  2021-01-01       Impact factor: 5.325

Review 7.  Tumour necrosis factor inhibitors in inflammatory bowel disease: the story continues.

Authors:  Laurent Peyrin-Biroulet; William J Sandborn; Remo Panaccione; Eugeni Domènech; Lieven Pouillon; Britta Siegmund; Silvio Danese; Subrata Ghosh
Journal:  Therap Adv Gastroenterol       Date:  2021-12-09       Impact factor: 4.409

  7 in total

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