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-Reference-Cited by-同舟云学术

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

Published:2018-03-07 Issue: Volume: Page:annrheumdis-2017-212245
ISSN:0003-4967
Container-title:Annals of the Rheumatic Diseases
language:en
Short-container-title:Ann Rheum Dis

Author:

Cohen Stanley B,Alonso-Ruiz Alberto,Klimiuk Piotr A,Lee Eric C,Peter Nuala,Sonderegger Ivo,Assudani Deepak

Funder

Boehringer Ingelheim

Publisher

BMJ

Subject

General Biochemistry, Genetics and Molecular Biology,Immunology,Immunology and Allergy,Rheumatology

Reference23 articles.

1. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. 2012. https://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

2. European Medicines Agency. Guideline on similar biological medicinal products. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

3. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf

4. Projecting future drug expenditures--2012;Hoffman;Am J Health Syst Pharm,2012

5. New tumour necrosis factor inhibitors for rheumatoid arthritis: are there benefits from extending choice?;Scott;Ann Rheum Dis,2009

Cited by 97 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Acceptability of CYLTEZO pen among biologics autoinjector patients, autoinjector Naïve patients, and healthcare professionals;Expert Opinion on Drug Delivery;2024-08-28

2. Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA;Rheumatology and Therapy;2024-08-09

3. Anti-TNFα in inflammatory bowel disease: from originators to biosimilars;Frontiers in Pharmacology;2024-07-24

4. Effect of treatment with original or biosimilar adalimumab on SARS-CoV2 vaccination antibody titers;International Journal of Pharmaceutics: X;2024-06

5. A narrative review of the comparative safety of disease-modifying anti-rheumatic drugs used for the treatment of rheumatoid arthritis;Expert Opinion on Drug Safety;2024-05-23