The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects

Author:

Declerck Paul,Danesi Romano,Petersel Danielle,Jacobs Ira

Funder

Pfizer

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Reference35 articles.

1. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs) Expert Committee on Biological Standardization, Geneva, Switzerland. 2009 (last update 23 Oct 2009). http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf Accessed 17 Mar 2016.

2. European Medicines Agency. Guideline on similar biological medicinal products (CHMP/437/04 Rev 1). European Medicines Agency, London. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf Accessed 11 May 2016.

3. European Medicines Agency. European public assessment reports by type (biosimilars). European Medicines Agency, London. 2016. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&keyword=Enter%20keywords&searchType=name&alreadyLoaded=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&jsenabled=false&searchGenericType=biosimilars&orderBy=status&pageNo=1 . Accessed 26 Apr 2016.

4. US Food and Drug Administration. FDA approves first biosimilar product Zarxio [media release]. US Department of Health and Human Services, Food and Drug Administration, Silver Spring, MD. 2015 (last update 6 Mar 2015). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm . Accessed 11 May 2016.

5. Generics and Biosimilars Initiative (GaBi). US$67 billion worth of biosimilar patents expiring before 2020. Pro Pharma Communications International, Mol, Belgium. 2012 (last update 20 Jan 2014). http://www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020 . Accessed 11 May 2016.

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