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Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme.

Related Articles Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme. J Crohns Colitis. 2017 Jan 27;: Authors: Razanskaite V, Bettey M, Downey L, Wright J, Callaghan J, Rush M, Whiteoak S, Ker S, Perry K, Underhill C, Efrem E, Ahmed I, Cummings F Abstract BACKGROUND AND AIMS: Biosimilar infliximab CT-P13 offers the potential for large drug acquisition cost savings. However, there are limited published data regarding its efficacy, safety, and immunogenicity in inflammatory bowel disease [IBD], particularly in switching IBD patients from originator to biosimilar infliximab….

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Biosimilars in inflammatory bowel disease: A review of post-marketing experience.

Related Articles Biosimilars in inflammatory bowel disease: A review of post-marketing experience. World J Gastroenterol. 2017 Jan 14;23(2):197-203 Authors: Deiana S, Gabbani T, Annese V Abstract Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist…

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

The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar. Inflamm Bowel Dis. 2017 Jan 12;: Authors: Fiorino G, Manetti N, Armuzzi A, Orlando A, Variola A, Bonovas S, Bossa F, Maconi G, DʼIncà R, Lionetti P, Cantoro L, Fries W, Annunziata ML, Costa F, Terpin MM, Biancone L, Cortelezzi CC, Amato A, Ardizzone S, Danese S, Guidi L, Rizzuto G, Massella A, Andriulli A, Massari A, Lorenzon G, Ghione S, Kohn A, Ventra A, Annese V, PROSIT-BIO Cohort Abstract BACKGROUND: Few data…

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

Related Articles ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease-An Update. J Crohns Colitis. 2016 Dec 07;: Authors: Danese S, Fiorino G, Raine T, Ferrante M, Kemp K, Kierkus J, Lakatos PL, Mantzaris G, van der Woude J, Panes J, Peyrin-Biroulet L PMID: 27927718 [PubMed – as supplied by publisher] PubMed Link: https://www.ncbi.nlm.nih.gov/pubmed/27927718?dopt=Abstract

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Efficacy of Infliximab Biosimilar CT-P13 Induction Therapy on Mucosal Healing in Ulcerative Colitis.

Related Articles Efficacy of Infliximab Biosimilar CT-P13 Induction Therapy on Mucosal Healing in Ulcerative Colitis. J Crohns Colitis. 2016 Nov;10(11):1273-1278 Authors: Farkas K, Rutka M, Golovics PA, Végh Z, Lovász BD, Nyári T, Gecse KB, Kolar M, Bortlik M, Duricova D, Machkova N, Hruba V, Lukas M, Mitrova K, Malickova K, Bálint A, Nagy F, Bor R, Milassin Á, Szepes Z, Palatka K, Lakatos PL, Lukas M, Molnár T Abstract INTRODUCTION: CT-P13 is the first biosimilar to infliximab that has been approved for the same indications as its originator infliximab….

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Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study.

Related Articles Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study. J Crohns Colitis. 2016 Nov;10(11):1287-1293 Authors: Smits LJ, Derikx LA, de Jong DJ, Boshuizen RS, van Esch AA, Drenth JP, Hoentjen F Abstract BACKGROUND AND AIMS: The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade®…

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Changes in Biosimilar Knowledge among European Crohn’s Colitis Organization [ECCO] Members: An Updated Survey.

Related Articles Changes in Biosimilar Knowledge among European Crohn’s Colitis Organization [ECCO] Members: An Updated Survey. J Crohns Colitis. 2016 Nov;10(11):1362-1365 Authors: Danese S, Fiorino G, Michetti P Abstract BACKGROUND: In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. We aimed to look at the evolution of IBD specialists’ thinking about biosimilars one year after they had become available in the European Union. METHODS: A 14-question anonymous survey was posted on the ECCO website. Members voluntarily…

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Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases.

Related Articles Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther. 2013 Oct;38(8):914-24 Authors: Rinaudo-Gaujous M, Paul S, Tedesco ED, Genin C, Roblin X, Peyrin-Biroulet L Abstract BACKGROUND: A biosimilar is a copy version of an approved original biological medicine whose data protection has expired. AIM: To provide an overview of the development of biosimilars worldwide. METHODS: Literature review of manufacturing processes of biosimilars, differences and similarities between biosimilars and the reference product, approval pathways for biosimilars, challenges in clinical trial study…

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ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD).

Related Articles ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013 Aug;7(7):586-9 Authors: Danese S, Gomollon F, Governing Board and Operational Board of ECCO Abstract Biologics have become key agents for the management of Crohn’s disease and ulcerative colitis. Biosimilars are biological medicines similar to previously authorized biologics and are already available in some countries. This ECCO Position Statement defines the collective view of European specialist in inflammatory bowel disease (IBD) concerning biosimilars. Biosimilars are not comparable to generic…

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