Pharmacoeconomics of Biosimilars: What Is There to Gain from Them?-Reference-Cited by-同舟云学术

Pharmacoeconomics of Biosimilars: What Is There to Gain from Them?

Published:2016-07-11 Issue:8 Volume:18 Page:
ISSN:1523-3774
Container-title:Current Rheumatology Reports
language:en
Short-container-title:Curr Rheumatol Rep

Author:

Araújo Filipe C.,Gonçalves João,Fonseca João Eurico

Publisher

Springer Science and Business Media LLC

Subject

Rheumatology

Link

http://link.springer.com/content/pdf/10.1007/s11926-016-0601-0.pdf

Reference63 articles.

1. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf . Accessed 21 Feb 2016.

2. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf . Accessed 21 Feb 2016.

3. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf . Accessed 21 Feb 2016.

4. World Health Organisation. Guidelines on evaluation of similar biotherapeutic products. 2009. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf . Accessed 21 Feb 2016.

5. U.S. Food and Drug Administration. scientific considerations in demonstrating biosimilarity to a reference product—Guidance for Industry. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf . Accessed 21 Feb 2016.

Cited by 26 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. A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars: An ISPOR Special Interest Group Report;Value in Health;2023-08

2. Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry;RMD Open;2022-11

3. Implementing and Optimizing Biosimilar Use at Mayo Clinic;Mayo Clinic Proceedings;2022-06

4. Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial;Annals of the Rheumatic Diseases;2021-04-29

5. Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar;RMD Open;2021-01