Biosimilars in the treatment of rheumatoid arthritis: a pharmacokinetic overview

Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: randomized study in healthy Japanese adults

(2023) Miwa Haranaka et al.   Immunotherapy

Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective

(2023) Hillel P. Cohen et al.   BIODRUGS

Perspectives on Subcutaneous Infliximab for Rheumatic Diseases and Inflammatory Bowel Disease: Before, During, and After the COVID-19 Era

(2022) Stefan Schreiber et al.   ADVANCES IN THERAPY

A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST)

(2022) Christopher Wynne et al.   EXPERT OPINION ON INVESTIGATIONAL DRUGS

Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants

(2022) Takuma Yonemura et al.   BMC Pharmacology & Toxicology

EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases

(2022) Charlotte LM Krieckaert et al.   ANNALS OF THE RHEUMATIC DISEASES

Re-Routing Infliximab Therapy: Subcutaneous Infliximab Opens a Path Towards Greater Convenience and Clinical Benefit

(2022) Rieke Alten et al.   CLINICAL DRUG INVESTIGATION

Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies

(2022) Hillel P. Cohen et al.   BIODRUGS

Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine

(2022) Johanna Elin Gehin et al.   BIODRUGS

Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

(2022) Andreas Kerschbaumer et al.   ANNALS OF THE RHEUMATIC DISEASES

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update

(2022) Josef S Smolen et al.   ANNALS OF THE RHEUMATIC DISEASES

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

(2022) Alexandre Sepriano et al.   ANNALS OF THE RHEUMATIC DISEASES

Patient knowledge about biosimilars and satisfaction with the education provided by rheumatologists or nurse specialists in a biosimilar multiswitch scenario – The perception study

(2022) Sabina Gall et al.   SEMINARS IN ARTHRITIS AND RHEUMATISM

Immunogenicity Challenges Associated with Subcutaneous Delivery of Therapeutic Proteins

(2021) Nicole L. Jarvi et al.   BIODRUGS

Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

(2021) Kyung‐Sang Yu et al.   CTS-Clinical and Translational Science

Randomized Controlled Trial: Subcutaneous versus Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

(2021) Stefan Schreiber et al.   GASTROENTEROLOGY

Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis

(2021) Daniel E Furst et al.   RHEUMATOLOGY

Cost-Effectiveness of Therapeutic Drug Monitoring-Guided Adalimumab Therapy in Rheumatic Diseases: A Prospective, Pragmatic Trial

(2021) Catalina Gómez-Arango et al.   Rheumatology and Therapy

Population pharmacokinetics of subcutaneous infliximab CT‐P13 in Crohn’s disease and ulcerative colitis

(2021) Jurij Hanzel et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Switching between reference adalimumab and biosimilars in chronic immune‐mediated inflammatory diseases: A systematic literature review

(2021) Nerea García‐Beloso et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

CT-P13 SC for the treatment of rheumatoid arthritis

(2021) Rene Westhovens   Expert Review of Clinical Immunology

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial

(2020) Stanley B. Cohen et al.   BIODRUGS

Effects of Successive Switches to Different Biosimilars Infliximab on Immunogenicity in Chronic Inflammatory Diseases in Daily Clinical Practice

(2020) Ambre Lauret et al.   SEMINARS IN ARTHRITIS AND RHEUMATISM

Personalized medicine in rheumatoid arthritis: How immunogenicity impacts use of TNF inhibitors

(2020) Caterina Bodio et al.   AUTOIMMUNITY REVIEWS

An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

(2020) Mustafa Shennak et al.   EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS

Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis

(2020) P Emery et al.   SCANDINAVIAN JOURNAL OF RHEUMATOLOGY

A Randomized, Double‐Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis

(2020) Gerd Burmester et al.   Clinical Pharmacology in Drug Development

Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis

(2020) Gerd Burmester et al.   CLINICAL RHEUMATOLOGY

Immunogenicity of biologic agents in rheumatology

(2020) Vibeke Strand et al.   Nature Reviews Rheumatology

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

(2020) Rene Westhovens et al.   RHEUMATOLOGY

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity

(2020) Tom W. J. Huizinga et al.   Rheumatology and Therapy

GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods

(2019) Oliver von Richter et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial

(2019) Seung Cheol Shim et al.   RHEUMATOLOGY

Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext)

(2019) Stanley B. Cohen et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

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

(2019) Vibeke Strand et al.   BIODRUGS

Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single‐Blind, Single‐Dose, Parallel‐Group Study in Healthy Subjects

(2019) Vincent Chow et al.   Clinical Pharmacology in Drug Development

FDA and EMA Biosimilar Approvals

(2019) Emily H. Jung et al.   JOURNAL OF GENERAL INTERNAL MEDICINE

Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study

(2018) Stanley B Cohen et al.   ANNALS OF THE RHEUMATIC DISEASES

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

A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01)

(2018) Ramesh Palaparthy et al.   Expert Review of Clinical Immunology

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

Drug safety and immunogenicity of tumour necrosis factor inhibitors: the story so far

(2018) Meghna Jani et al.   RHEUMATOLOGY

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

Rheumatoid arthritis

(2018) Josef S. Smolen et al.   Nature Reviews Disease Primers

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

Biological anti-TNF drugs: immunogenicity underlying treatment failure and adverse events

(2017) Mônica Simon Prado et al.   Expert Opinion on Drug Metabolism & Toxicology

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

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

Biosimilars in rheumatology: A review of the evidence and their place in the treatment algorithm

(2017) Hendrik Schulze-Koops et al.   RHEUMATOLOGY

Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons

(2017) Till Uhlig 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

The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study

(2017) Robert J. Moots et al.   PLoS One

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

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

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

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

GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes

(2016) Oliver von Richter 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

The underlying inflammatory chronic disease influences infliximab pharmacokinetics

(2016) Christophe Passot et al.   mAbs

Immunogenicity to Biotherapeutics – The Role of Anti-drug Immune Complexes

(2016) Murli Krishna et al.   Frontiers in Immunology

Towards optimal cut-off trough levels of adalimumab and etanercept for a good therapeutic response in rheumatoid arthritis. Results of the INMUNOREMAR study

(2015) Raimon Sanmarti et al.   ANNALS OF THE RHEUMATIC DISEASES

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

Lower education and living in countries with lower wealth are associated with higher disease activity in rheumatoid arthritis: results from the multinational COMORA study

(2015) Polina Putrik 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

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

Clinical utility of random anti-tumour necrosis factor drug testing and measurement of anti-drug antibodies on long-term treatment response in rheumatoid arthritis

(2015) Meghna Jani et al.   LANCET

Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis

(2014) Der-Yuan Chen et al.   ANNALS OF THE RHEUMATIC DISEASES

Monitoring Drug and Antidrug Levels: A Rational Approach in Rheumatoid Arthritis Patients Treated with Biologic Agents Who Experience Inadequate Response While Being on a Stable Biologic Treatment

(2014) Diana Mazilu et al.   Biomed Research International

Personalised treatment using serum drug levels of adalimumab in patients with rheumatoid arthritis: an evaluation of costs and effects

(2013) C L M Krieckaert et al.   ANNALS OF THE RHEUMATIC DISEASES

Key findings towards optimising adalimumab treatment: the concentration–effect curve

(2013) Mieke F Pouw et al.   ANNALS OF THE RHEUMATIC DISEASES

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

The combined use of disease activity and infliximab serum trough concentrations for early prediction of (non-)response to infliximab in rheumatoid arthritis

(2013) Bart J. F. van den Bemt et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Drug levels, anti-drug antibodies, and clinical efficacy of the anti-TNFα biologics in rheumatic diseases

(2013) C. C. Mok et al.   CLINICAL RHEUMATOLOGY

Anti-TNF treatments in rheumatoid arthritis: economic impact of dosage modification

(2013) Inmaculada de la Torre et al.   Expert Review of Pharmacoeconomics & Outcomes Research

Immunogenicity and autoimmunity during anti-TNF therapy

(2012) F. Atzeni et al.   AUTOIMMUNITY REVIEWS

Transient Low-Dose Methotrexate Induces Tolerance to Murine Anti-Thymocyte Globulin and Together They Promote Long-Term Allograft Survival

(2012) A. Joseph et al.   JOURNAL OF IMMUNOLOGY

Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST-RA database

(2009) T Sokka et al.   ANNALS OF THE RHEUMATIC DISEASES