Notes
1The use of trade names is for product identification purposes only and does not imply endorsement.
References
WHO. International nonproprietary names. Geneva: WHO [online]. Available from URL: http://www.who.int/medicines/services/inn/en/ [Accessed 2007 Oct 8]
Guidance on INN. Geneva: WHO [online]. Available from URL: http://www.who.int/medicines/services/inn/innguidance/en/index.html [Accessed 2007 Nov 1]
EMEA guidelines on similar biological medicinal products. London: EMEA, 2005. Document no.: EMEA/CHMP/437/04
European Medicines Agency adopts first positive opinion for a similar biological medicinal product [press release]. London: EMEA, 2006 Jan 27. Document no.: EMEA/31797/2006 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/press/pr/3179706en.pdf [Accessed 2007 Nov 1]
Committee for Medicinal Products for Human Use. February 2006 plenary meeting: monthly report. London: EMEA, 2006 Mar 17. Document no.: CHMP/70961/2006 Rev.1 [online]. Available from URL: http://www.emea.europa.eu/pdfs/ human/press/pr/7096106en.pdf [Accessed 2007 Nov 1]
Questions and answers on recommendation for refusal of marketing application for alpheon. London: EMEA, 2006 Jun 28. Document no.: EMEA/190896/2006 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/opinion/19089606en.pdf [Accessed 2007 Nov 1]
Meeting highlights from the Committee for Medicinal Products for Human Use, 18–21 June 2007 [press release]. London: EMEA, 2007 Jun 22. Document no.: EMEA/267556/2007 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/press/pr/26755607en.pdf [Accessed 2007 Nov 1]
Schellekens H. Follow-on biologics: challenges of the ‘next generation’. Nephrol Dial Transplant2005; 20 Suppl. 4: 31–6
Projet de loi portant diverses dispositions d’adaptation au droit communautaire dans le domaine du medicament. Legifrance [online]. Available from URL: http://www.legifrance.gouv.fr/html/actualite/actualite_legislative/exp_ddac_medicament.htm [Accessed 2007 Nov 1]
US FDA considerations: discussion by National Regulatory Authorities with World Health Organization (WHO) on possible international non-proprietary name (INN) policies for biosimilars. 2006 Sep 1. FDA [online]. Available from URL: http://www.fda.gov/cder/news/biosimilars.htm [Accessed 2007 Oct 9]
European Generic Medicines Association (EGA). Biosimilar products: a reality in Europe [press release]. 2006 May 18. EGA [online]. Available from URL: http://www.egagenerics.com/pr-2006-05-18.htm [Accessed 2007 Oct 9]
European Biopharmaceutical Enterprises (EBE) naming of biotech medicines including biosimilars: WHO meeting positive for innovator industry. EBE, 2006 [online]. Available from URL: http://www.ebe-biopharma.org/index.php?option=com_news&task=view&id=74&Itemid=67&lang=en [Accessed 2007 Nov 1]
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No sources of funding were used to assist in the preparation of this commentary. The author has no conflicts of interest that are directly relevant to the content of this article.
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Declerck, P.J. Biotherapeutics in the Era of Biosimilars. Drug-Safety 30, 1087–1092 (2007). https://doi.org/10.2165/00002018-200730120-00002
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DOI: https://doi.org/10.2165/00002018-200730120-00002