Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons
出版年份 2017 全文链接
标题
Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons
作者
关键词
-
出版物
RHEUMATOLOGY
Volume 56, Issue suppl_4, Pages iv49-iv62
出版商
Oxford University Press (OUP)
发表日期
2017-08-10
DOI
10.1093/rheumatology/kex276
参考文献
相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。- 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
- Reporting of potential immunogenicity with biologic drugs: clarity and accuracy required
- (2016) Robert J Moots et al. ANNALS OF THE RHEUMATIC DISEASES
- Response to: ‘Reporting of potential immunogenicity with biologic drugs: clarity and accuracy required’ by Mootset al: Table 1
- (2016) Paul Emery et al. ANNALS OF THE RHEUMATIC DISEASES
- THU0150 Long-Term Safety and Efficacy of SB4 (Etanercept Biosimilar) in Patients with Rheumatoid Arthritis: Comparison between Continuing SB4 and Switching from Etanercept Reference Product To SB4
- (2016) P. Emery 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
- 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
- Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health
- (2016) Jürgen Braun et al. BIOLOGICALS
- 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
- Biosimilars in Inflammatory Bowel Disease: Facts and Fears of Extrapolation
- (2016) Shomron Ben-Horin et al. Clinical Gastroenterology and Hepatology
- Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents
- (2016) Balázs Vezér et al. CURRENT MEDICAL RESEARCH AND OPINION
- Bioavailability, safety and immunogenicity of biosimilar infliximab (BOW015) compared to reference infliximab
- (2016) John Lambert et al. INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
- 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
- Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial
- (2016) Duncan Porter et al. LANCET
- Patient attitudes and understanding about biosimilars: an international cross-sectional survey
- (2016) Ira Jacobs et al. Patient Preference and Adherence
- Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying antirheumatic drugs for rheumatoid arthritis: abridged Cochrane systematic review and network meta-analysis
- (2016) Glen S Hazlewood et al. BMJ-British Medical Journal
- Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial
- (2016) Espen A Haavardsholm et al. BMJ-British Medical Journal
- Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying antirheumatic drugs for rheumatoid arthritis: abridged Cochrane systematic review and network meta-analysis
- (2016) Glen S Hazlewood et al. BMJ-British Medical Journal
- Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial
- (2016) Espen A Haavardsholm et al. BMJ-British Medical Journal
- The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries
- (2015) Ashok Jha et al. ADVANCES IN THERAPY
- 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
- Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data
- (2015) Elena Nikiphorou et al. EXPERT OPINION ON BIOLOGICAL THERAPY
- Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody
- (2015) J. D. Isaacs et al. JOURNAL OF INTERNAL MEDICINE
- Treatment preferences of originator versus biosimilar drugs in Crohn’s disease; discrete choice experiment among gastroenterologists
- (2015) Petra Baji et al. SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY
- Biological therapy in inflammatory bowel diseases: Access in Central and Eastern Europe
- (2015) Fanni Rencz WORLD JOURNAL OF GASTROENTEROLOGY
- Comparative immunogenicity assessment: a critical consideration for biosimilar development
- (2015) Patrick M Liu et al. Bioanalysis
- 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
- Traceability of biologicals: present challenges in pharmacovigilance
- (2014) Niels S Vermeer et al. Expert Opinion On Drug Safety
- Randomised controlled trial of Tumour necrosis factor inhibitors Against Combination Intensive Therapy with conventional disease-modifying antirheumatic drugs in established rheumatoid arthritis: the TACIT trial and associated systematic reviews
- (2014) David L Scott et al. HEALTH TECHNOLOGY ASSESSMENT
- Viewpoint: Knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization
- (2014) Silvio Danese et al. Journal of Crohns & Colitis
- The Burden of Disease in Rheumatoid Arthritis
- (2014) Till Uhlig et al. PHARMACOECONOMICS
- Pharmacoeconomics of Cancer Therapies: Considerations With the Introduction of Biosimilars
- (2014) David Henry et al. SEMINARS IN ONCOLOGY
- Biosimilars in rheumatology: the wind of change
- (2013) Christian K Schneider ANNALS OF THE RHEUMATIC DISEASES
- Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country's wealth?
- (2013) Polina Putrik 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
- Inequities in access to biologic and synthetic DMARDs across 46 European countries
- (2013) Polina Putrik et al. ANNALS OF THE RHEUMATIC DISEASES
- EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update
- (2013) Josef S Smolen et al. ANNALS OF THE RHEUMATIC DISEASES
- Author’s Reply to Borg et al. Comment on: “EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars”
- (2013) Begoña Calvo DRUG SAFETY
- EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars
- (2013) Begoña Calvo et al. DRUG SAFETY
- Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial
- (2013) Josef S Smolen et al. LANCET
- Approval of the first biosimilar antibodies in Europe
- (2013) Alain Beck et al. mAbs
- Introduction of an Infliximab Biosimilar (CT-P13): A Five-Year Budget Impact Analysis for the Treatment of Rheumatoid Arthritis in Ireland
- (2013) G. McCarthy et al. VALUE IN HEALTH
- Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations
- (2013) Paul Chamberlain Bioanalysis
- Interchangeability, immunogenicity and biosimilars
- (2012) Hans C Ebbers et al. NATURE BIOTECHNOLOGY
- Biosimilar, biobetter and next generation therapeutic antibodies
- (2011) Alain Beck mAbs
- Stability of IgG isotypes in serum
- (2010) Ivan Correia mAbs
- 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
Find the ideal target journal for your manuscript
Explore over 38,000 international journals covering a vast array of academic fields.
SearchCreate your own webinar
Interested in hosting your own webinar? Check the schedule and propose your idea to the Peeref Content Team.
Create Now