Inflammatory bowel disease: an overview of immune mechanisms and biological treatments

BRR de Mattos, MPG Garcia… - Mediators of …, 2015 - Wiley Online Library
Inflammatory bowel diseases (IBD) are characterized by chronic inflammation of the
intestinal tract associated with an imbalance of the intestinal microbiota. Crohn's disease …

Biosimilars in rheumatology: current perspectives and lessons learnt

T Dörner, J Kay - Nature Reviews Rheumatology, 2015 - nature.com
Biosimilars, based on biopharmaceuticals approved by regulatory agencies that are no
longer under patent protection, have efficacy and safety comparable to their reference …

Biosimilars: the science of extrapolation

M Weise, P Kurki, E Wolff-Holz… - Blood, The Journal …, 2014 - ashpublications.org
Despite the establishment of a specific approval pathway, the issuance of detailed scientific
guidelines for the development of similar biological medicinal products (so-called …

Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases

J Kay, MM Schoels, T Dörner, P Emery… - Annals of the …, 2018 - ard.bmj.com
The study aimed to develop evidence-based recommendations regarding the evaluation
and use of biosimilars to treat rheumatological diseases. The task force comprised an expert …

Interchangeability of biosimilars: a European perspective

P Kurki, L van Aerts, E Wolff-Holz, T Giezen, V Skibeli… - BioDrugs, 2017 - Springer
Many of the best-selling 'blockbuster'biological medicinal products are, or will soon be,
facing competition from similar biological medicinal products (biosimilars) in the EU …

Efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study

YS Jung, DI Park, YH Kim, JH Lee… - Journal of …, 2015 - Wiley Online Library
Abstract Background and Aim The biosimilar of infliximab, CT‐P13, has recently been
shown to be equivalent to infliximab in both efficacy and safety in the treatment of …

Is there a reason for concern or is it just hype?–A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars

A Inotai, CPJ Prins, M Csanádi, D Vitezic… - Expert opinion on …, 2017 - Taylor & Francis
Introduction: While prescribing biosimilars to patients naive to a biologic treatment is a well-
accepted practice, switching clinically stable patients from an originator to a biosimilar is an …

pharmacological aspects of anti‐TNF biosimilars in inflammatory bowel diseases

K Papamichael, T Van Stappen… - Alimentary …, 2015 - Wiley Online Library
Background Anti‐tumour necrosis factor (anti‐TNF) monoclonal antibodies have shown
efficacy in inflammatory bowel diseases (IBD). As these therapies lose patent protection …

Use of biosimilars in pediatric inflammatory bowel disease: an updated position statement of the Pediatric IBD Porto Group of ESPGHAN

L De Ridder, A Assa, J Bronsky… - Journal of pediatric …, 2019 - journals.lww.com
Biologic therapies have changed the outcome of both adult and pediatric patients with
Inflammatory Bowel Disease (IBD). In September 2013, the first biosimilar of infliximab was …

[HTML][HTML] Biosimilars for the treatment of chronic inflammatory diseases: a systematic review of published evidence

I Jacobs, D Petersel, L Isakov, S Lula, K Lea Sewell - BioDrugs, 2016 - Springer
Background Clinicians are required to assimilate, critically evaluate, and extrapolate
information to support appropriate use of biosimilars across indications. Objectives The …