The future of biosimilars: maximizing benefits across immune-mediated inflammatory diseases

HU Kim, R Alten, L Avedano, A Dignass, F Gomollón… - Drugs, 2020 - Springer
Biologics have transformed the treatment of immune-mediated inflammatory diseases such
as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars—biologic …

TNF-alpha blockers in inflammatory bowel diseases: practical recommendations and a user's guide: an update

M Vulliemoz, S Brand, P Juillerat, C Mottet… - Digestion, 2020 - karger.com
Background: Anti-tumour necrosis factor-alpha (anti-TNF) antagonists have been the
mainstay in the treatment of inflammatory bowel diseases (IBDs) for over 20 years …

[HTML][HTML] Randomized controlled trial: subcutaneous vs intravenous infliximab CT-P13 maintenance in inflammatory bowel disease

S Schreiber, S Ben-Horin, J Leszczyszyn, R Dudkowiak… - Gastroenterology, 2021 - Elsevier
Background & aims This study compared pharmacokinetics, symptomatic and endoscopic
efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab …

Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial

R Westhovens, P Wiland, M Zawadzki, D Ivanova… - …, 2021 - academic.oup.com
Objective To assess non-inferiority of sc to iv CT-P13 in RA. Methods Patients with active RA
and inadequate response to MTX participated in this phase I/III double-blind study at 76 …

Therapeutic drug monitoring of subcutaneous infliximab in inflammatory bowel disease—understanding pharmacokinetics and exposure response relationships in a …

RD Little, MG Ward, E Wright, AJ Jois… - Journal of Clinical …, 2022 - mdpi.com
CT-P13 is the first subcutaneous infliximab molecule approved for the management of
inflammatory bowel disease (IBD). Compared to intravenous therapy, SC infliximab offers a …

Re-routing infliximab therapy: subcutaneous infliximab opens a path towards greater convenience and clinical benefit

R Alten, Y An, DH Kim, SW Yoon… - Clinical Drug …, 2022 - Springer
Subcutaneous infliximab recently received approval for the treatment of various immune-
mediated inflammatory diseases in Europe, following pivotal clinical trials in patients with …

Biosimilars: a value proposition

F De Mora - BioDrugs, 2019 - Springer
Biosimilars are biological agents that effectively replicate original reference products. The
main driver of their development is the promise of bringing competition into the marketplace …

Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters

HU Kim, R Alten, F Cummings, S Danese, G D'Haens… - MAbs, 2021 - Taylor & Francis
The biosimilar concept is now well established. Clinical data accumulated pre-and post-
approval have supported biosimilar uptake, in turn stimulating competition in the biologics …

Evolution of infliximab biosimilar in inflammatory bowel disease: from intravenous to subcutaneous CT-P13

TL Parigi, F D'Amico, L Peyrin-Biroulet… - Expert Opinion on …, 2021 - Taylor & Francis
Introduction Biologic drugs have significantly improved the treatment of ulcerative colitis
(UC) and Crohn's disease (CD). However, the availability of these drugs is limited by their …

[HTML][HTML] Higher infliximab and adalimumab trough levels are associated with fistula healing in patients with fistulising perianal Crohn's disease

B Gu, K Venkatesh, AJ Williams, W Ng… - World journal of …, 2022 - ncbi.nlm.nih.gov
BACKGROUND Tumor necrosis factor-alpha inhibitors, including infliximab and
adalimumab, are effective medical treatments for perianal fistulising Crohn's disease (CD) …