The biosimilar name debate: what's at stake for public health

GaBI Journal

Volumn 3, Issue 1, 2014, Pages 10-12

  Alexander, Emily A ^a  

^a ABBVIE INC   (United States)

Author keywords

Adverse event reporting; Biosimilars; Naming

Indexed keywords

EID: 85008260072     PISSN: 20336403     EISSN: 20336772     Source Type: Journal    
DOI: 10.5639/gabij.2014.0301.005     Document Type: Note

References (12)

1. World Health Organization. 56th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. Geneva, 15-17 April 2013. Executive Summary. September 2013 [homepage on the Internet]. 2013 Oct [cited 2014 Jan 9]. Available from: http://www.who.int/ medicines/services/inn/56th_Executive_Summary.pdf
2. European Medicines Agency. Silapo: EPAR - Scientific Discussion. January 2008 [homepage on the Internet]. 2008 Jan [cited 2014 Jan 9]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000760/WC500050914.pdf
3. European Medicines Agency. Assessment Report: Remsima. 27 June 2013 [homepage on the Internet]. 2014 [cited 2014 Jan 9]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf
4. Australian Government. Department of Health. Therapeutic Goods Administration. Evaluation of biosimilars. 30 July 2013 [homepage on the Internet]. 2014 [cited 2014 Jan 9]. Available from: http://www.tga.gov.au/industry/pm-argpm-biosimilars-00.htm#.Usn2XjOA3Dd
5. Arato T. Recent regulations of biosimilars in Japan. Pharmaceuticals and Medical Devices Agency. 47th Annual Meeting, DIA 2011; 2011 Jun 19-23, Chicago, USA. Available from: http://www.pmda.go.jp/regulatory/file/english_presentation/biologics/B-E1arato.pdf
6. Derbyshire M. Biosimilar development and regulation in Japan. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):207-8. doi:10.5639/gabij.2013.0204.055
7. U.S. Food and Drug Administration. Public Health Service. Department of Health and Human Services. FDA Biological Product Naming Working Group, FDA Memorandum, BLA 125294 - [xxx]-filgrastim. 2 August 2012 [homepage on the Internet]. [cited 2014 Jan 9]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000NameR.pdf
8. Industry Standard Research. Alliance for Safe Biologic Medicine - Prescriber survey [homepage on the Internet]. 2012 Aug 31 [cited 2014 Jan 9]. Available from: http://safebiologics.org/resources/wp-content/uploads/2012/09/ASBM-Survey-1.pdf
9. Alliance for Safe Biologic Medicines. ASBM presents new European survey findings on biosimilars and the importance of nonproprietary naming [homepage on the Internet]. 2013 Nov 22 [cited 2014 Jan 9]. Available from: http://safebiologics.org/resources/2013/11/asbm-presentsnew- european-survey-findings-on-biosimilars-and-the-importance-of-nonproprietary-naming
10. Prescriber Survey. ZS Associates on behalf of AbbVie. 2013. Data on file at AbbVie.
11. Biosimilar medicines and safety: new challenges for pharmacovigilance. WHO Drug Information. 2009;23(2):87-91. Available from: http:// apps.who.int/medicinedocs/documents/s16240e/s16240e.pdf
12. Lietzan E, et al. Biosimilar naming: how do adverse event reporting data support the need for distinct nonproprietary names for biosimilars? FDLI's Food and Drug Policy Forum. 2013;3(6):1-20.