Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community-Reference-Cited by-同舟云学术

Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community

Published:2017-04-24 Issue:3 Volume:31 Page:175-187
ISSN:1173-8804
Container-title:BioDrugs
language:en
Short-container-title:BioDrugs

Author:

Markus Richard,Liu Jennifer,Ramchandani Monica,Landa Diana,Born Teresa,Kaur Primal

Funder

Amgen

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Link

http://link.springer.com/article/10.1007/s40259-017-0218-5/fulltext.html

Reference46 articles.

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3. European Medicines Agency. Guideline on similar biological medicinal products. London, UK. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . Accessed 30 March 2016.

4. US Food and Drug Administration. Guidance for industry: biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009. Rockville, MD. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444661.pdf . Accessed 30 March 2016.

5. US Food and Drug Administration. Guidance for industry: quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Rockville, MD. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf . Accessed 30 March 2016.

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