Biosimilars in the United States: Emerging Issues in Litigation-Reference-Cited by-同舟云学术

Biosimilars in the United States: Emerging Issues in Litigation

Published:2017-04-19 Issue:3 Volume:31 Page:189-205
ISSN:1173-8804
Container-title:BioDrugs
language:en
Short-container-title:BioDrugs

Author:

Wong Alice Yuen-Ting^ORCID,Rumore Martha M.,Chan Albert Wai-Kit

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Link

http://link.springer.com/article/10.1007/s40259-017-0216-7/fulltext.html

Reference73 articles.

1. Food and Drug Administration. Licensed biological products with supporting documents. 2015. http://www.fda.gov/BiologicsBloodVaccines/ucm133705.htm . Accessed 22 Mar 2017.

2. Khanam R. Biosimilars are here. Now what? 2015. http://inmygroup.com/06/26/2016/biosimilars-are-here-now-what.html Accessed 22 Mar 2017.

3. Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benef. 2013;6:469–78.

4. Parker GE, Witwer S, Bowker GM. Regulatory approval of biosimilars: a global Queryperspective. Regul Focus. 2014:1–11.

5. European Medicines Agency. 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 22 March 2017.

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