The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13

The Role of Tumour Necrosis Factor in the Pathogenesis of Immune-Mediated Diseases

(2017) C. Blandizzi et al.   INTERNATIONAL JOURNAL OF IMMUNOPATHOLOGY AND PHARMACOLOGY

Anti-TNF Agents as Therapeutic Choice in Immune-Mediated Inflammatory Diseases: Focus on Adalimumab

(2017) A. Armuzzi et al.   INTERNATIONAL JOURNAL OF IMMUNOPATHOLOGY AND PHARMACOLOGY

Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis

(2015) Tsutomu Takeuchi et al.   Modern Rheumatology

Sa2031 Accelerated Clearance of Serum Infliximab During Induction Therapy for Acute Ulcerative Colitis is Associated With Treatment Failure.

(2015) David Kevans et al.   GASTROENTEROLOGY

The challenge of indication extrapolation for infliximab biosimilars

(2014) Brian G. Feagan et al.   BIOLOGICALS

Biosimilars: the science of extrapolation

(2014) M. Weise et al.   BLOOD

TNF and TNF-receptors: From mediators of cell death and inflammation to therapeutic giants – past, present and future

(2014) Lisa M. Sedger et al.   CYTOKINE & GROWTH FACTOR REVIEWS

Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series

(2014) Yun-Seong Kang et al.   DIGESTIVE DISEASES AND SCIENCES

Disequilibrium of M1 and M2 Macrophages Correlates with the Development of Experimental Inflammatory Bowel Diseases

(2014) Wei Zhu et al.   IMMUNOLOGICAL INVESTIGATIONS

Biosimilars: In support of extrapolation of indications

(2014) Hans C. Ebbers   Journal of Crohns & Colitis

Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α

(2014) David J. Shealy et al.   mAbs

Physicochemical characterization of Remsima®

(2014) Soon Kwan Jung et al.   mAbs

Tumour Necrosis Factor-α Regulates Human Eosinophil Apoptosis via Ligation of TNF-Receptor 1 and Balance between NF-κB and AP-1

(2014) Hannu Kankaanranta et al.   PLoS One

Therapeutic drug monitoring in patients with inflammatory bowel disease

(2014) Andres J Yarur   WORLD JOURNAL OF GASTROENTEROLOGY

Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

(2013) Howard Lee   AAPS Journal

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

(2013) Dae Hyun Yoo et al.   ANNALS OF THE RHEUMATIC DISEASES

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

(2013) Won Park et al.   ANNALS OF THE RHEUMATIC DISEASES

Anti-TNF Antibodies in Inflammatory Bowel Disease: Do We Finally Know How it Works?

(2013) Angelos Oikonomopoulos et al.   CURRENT DRUG TARGETS

Methotrexate in Combination With Infliximab Is No More Effective Than Infliximab Alone in Patients With Crohn's Disease

(2013) Brian G. Feagan et al.   GASTROENTEROLOGY

Combination Therapy With Infliximab and Azathioprine Is Superior to Monotherapy With Either Agent in Ulcerative Colitis

(2013) Remo Panaccione et al.   GASTROENTEROLOGY

The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab

(2013) Bella Ungar et al.   GUT

P500 Fecal loss of infliximab as a cause of lack of response in severe inflammatory bowel disease

(2013) J.F. Brandse et al.   Journal of Crohns & Colitis

Disclosure of the Culprits: Macrophages—Versatile Regulators of Wound Healing

(2013) Anca Sindrilaru et al.   Advances in Wound Care

p53 Mediates TNF-Induced Epithelial Cell Apoptosis in IBD

(2012) Tatiana Goretsky et al.   AMERICAN JOURNAL OF PATHOLOGY

Pharmacokinetic Properties of Infliximab in Children and Adults with Crohn's Disease: A Retrospective Analysis of Data from 2 Phase III Clinical Trials

(2011) Adedigbo A. Fasanmade et al.   CLINICAL THERAPEUTICS

Regulatory macrophages induced by infliximab are involved in healing in vivo and in vitro

(2011) Anne Christine W. Vos et al.   INFLAMMATORY BOWEL DISEASES

Enhand secretion of tumour necrosis factor-alpha, IL-6, and IL-1β by isolated lamina ropria monouclear cells from patients with ulcretive cilitis and Crohn's disease

(2010) H.-C. REINECKER et al.   CLINICAL AND EXPERIMENTAL IMMUNOLOGY

Anti–Tumor Necrosis Factor-α Antibodies Induce Regulatory Macrophages in an Fc Region-Dependent Manner

(2010) Anne Christine W. Vos et al.   GASTROENTEROLOGY

Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease

(2010) Jean Frédéric Colombel et al.   NEW ENGLAND JOURNAL OF MEDICINE

The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review

(2010) Charlotte Krieckaert et al.   ARTHRITIS RESEARCH & THERAPY

Differences in binding and effector functions between classes of TNF antagonists

(2009) Taruna Arora et al.   CYTOKINE

Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis

(2009) Adedigbo A. Fasanmade et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Mechanisms for cytotoxic effects of anti–tumor necrosis factor agents on transmembrane tumor necrosis factor α–expressing cells: Comparison among infliximab, etanercept, and adalimumab

(2008) Hiroki Mitoma et al.   ARTHRITIS AND RHEUMATISM

Tumor necrosis factor antagonist mechanisms of action: A comprehensive review

(2007) Daniel Tracey et al.   PHARMACOLOGY & THERAPEUTICS