Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents

Antigenic response to CT-P13 and infliximab originator in inflammatory bowel disease patients shows similar epitope recognition

(2018) J. Goncalves et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Efficacy and Safety Outcomes for Originator TNF Inhibitors and Biosimilars in Rheumatoid Arthritis and Psoriasis Trials: A Systematic Literature Review

(2018) Robert J. Moots et al.   BIODRUGS

Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches

(2018) A. Blauvelt et al.   BRITISH JOURNAL OF DERMATOLOGY

Comparison of injection-site reactions between the etanercept biosimilar SB4 and the reference etanercept in patients with rheumatoid arthritis from a phase III study

(2018) G. Girolomoni et al.   BRITISH JOURNAL OF DERMATOLOGY

Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab

(2018) B. Gorovits et al.   CLINICAL AND EXPERIMENTAL IMMUNOLOGY

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

(2018) Lisa J T Smits et al.   INFLAMMATORY BOWEL DISEASES

Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial

(2018) Won Park et al.   mAbs

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

(2018) Marte L. Høivik et al.   SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

An Extension Study of PF-05280586, a Potential Rituximab Biosimilar, versus Rituximab in Subjects with Active Rheumatoid Arthritis

(2018) Stanley B Cohen et al.   ARTHRITIS CARE & RESEARCH

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis

(2018) Michael E. Weinblatt et al.   Arthritis & Rheumatology

Network meta-analyses of systemic treatments for psoriasis: a critical appraisal

(2018) A.G. Ellis et al.   BRITISH JOURNAL OF DERMATOLOGY

Safety and Immunogenicity of Rituximab Biosimilar GP2013 After Switch From Reference Rituximab in Patients With Active Rheumatoid Arthritis

(2018) Hans-Peter Tony et al.   ARTHRITIS CARE & RESEARCH

Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort

(2017) Lorant Gonczi et al.   INFLAMMATORY BOWEL DISEASES

The Immunogenicity of Branded and Biosimilar Infliximab in Rheumatoid Arthritis According to Th9-Related Responses

(2017) Rossella Talotta et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers

(2017) D. Shin et al.   JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS

Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study

(2017) Kim Papp et al.   JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study

(2017) S. Gerdes et al.   JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

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

(2017) Kristin K Jørgensen et al.   LANCET

Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results

(2017) Josef S. Smolen et al.   RHEUMATOLOGY

52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis

(2017) Paul Emery et al.   RHEUMATOLOGY

Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid Arthritis

(2017) Michael E. Weinblatt et al.   Arthritis & Rheumatology

Subjective Complaints as the Main Reason for Biosimilar Discontinuation After Open-Label Transition From Reference Infliximab to Biosimilar Infliximab

(2017) Lieke Tweehuysen et al.   Arthritis & Rheumatology

A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab

(2016) Primal Kaur et al.   ANNALS OF THE RHEUMATIC DISEASES

OP0226 Randomized, Double-Blind Study Comparing Chs-0214 with Etanercept in Patients with Active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) Therapy

(2016) J. O'Dell et al.   ANNALS OF THE RHEUMATIC DISEASES

Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

(2016) Won Park et al.   ANNALS OF THE RHEUMATIC DISEASES

A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

(2016) Dae Hyun Yoo et al.   ANNALS OF THE RHEUMATIC DISEASES

Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars

(2016) M Begoña Ruiz-Argüello et al.   ANNALS OF THE RHEUMATIC DISEASES

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

(2016) Dae Hyun Yoo et al.   ANNALS OF THE RHEUMATIC DISEASES

The changing landscape of biosimilars in rheumatology

(2016) Thomas Dörner et al.   ANNALS OF THE RHEUMATIC DISEASES

Assessing the Immunogenicity of Biopharmaceuticals

(2016) Carlos Pineda et al.   BIODRUGS

Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira®in healthy subjects

(2016) Elizabeth Hyland et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects

(2016) Yoon Jung Lee et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis

(2016) Stanley Cohen et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

(2016) Christopher Wynne et al.   EXPERT OPINION ON INVESTIGATIONAL DRUGS

Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study

(2016) Maurizio Benucci et al.   IMMUNOLOGIC RESEARCH

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

(2016) Klaudia Farkas et al.   Journal of Crohns & Colitis

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

(2016) Lisa J. T. Smits et al.   Journal of Crohns & Colitis

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

(2015) Yow-Ming C. Wang et al.   AAPS Journal

A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy

(2015) Jung-Yoon Choe et al.   ANNALS OF THE RHEUMATIC DISEASES

A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy

(2015) Paul Emery et al.   ANNALS OF THE RHEUMATIC DISEASES

A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade®) in Healthy Subjects

(2015) Donghoon Shin et al.   BIODRUGS

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium

(2015) B. Rup et al.   CLINICAL AND EXPERIMENTAL IMMUNOLOGY

Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis – experiences from a single center

(2015) Klaudia Farkas et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study

(2015) Won Park et al.   Expert Review of Clinical Immunology

Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)

(2015) Ji Soo Kim et al.   Expert Review of Clinical Immunology

Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima

(2015) Shomron Ben-Horin et al.   GUT

A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis

(2015) Rajendrakumar H. Jani et al.   International Journal of Rheumatic Diseases

Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort

(2015) Krisztina B. Gecse et al.   Journal of Crohns & Colitis

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

2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

(2015) Jasvinder A. Singh et al.   ARTHRITIS CARE & RESEARCH

Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study

(2015) Jørgen Jahnsen et al.   Expert Review of Gastroenterology & Hepatology

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

(2014) G. Shankar et al.   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

The role of biosimilars in the treatment of rheumatic diseases

(2012) Thomas Dörner et al.   ANNALS OF THE RHEUMATIC DISEASES

Immunogenicity of biological therapeutics

(2012) Charlotte Krieckaert et al.   CURRENT OPINION IN RHEUMATOLOGY

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

(2010) Kenneth F Schulz et al.   BMC Medicine