Drug Safety

, Volume 30, Issue 12, pp 1087–1092 | Cite as

Biotherapeutics in the Era of Biosimilars

What Really Matters is Patient Safety



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.


  1. 1.
    WHO. International nonproprietary names. Geneva: WHO [online]. Available from URL: http://www.who.int/medicines/services/inn/en/ [Accessed 2007 Oct 8]Google Scholar
  2. 2.
    Guidance on INN. Geneva: WHO [online]. Available from URL: http://www.who.int/medicines/services/inn/innguidance/en/index.html [Accessed 2007 Nov 1]
  3. 3.
    EMEA guidelines on similar biological medicinal products. London: EMEA, 2005. Document no.: EMEA/CHMP/437/04Google Scholar
  4. 4.
    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]
  5. 5.
    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]Google Scholar
  6. 6.
    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]
  7. 7.
    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]
  8. 8.
    Schellekens H. Follow-on biologics: challenges of the ‘next generation’. Nephrol Dial Transplant2005; 20 Suppl. 4: 31–6CrossRefGoogle Scholar
  9. 9.
    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]
  10. 10.
    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]
  11. 11.
    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]
  12. 12.
    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]

Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  1. 1.Laboratory for Pharmaceutical Biology, Faculty of Pharmaceutical SciencesKatholieke Universiteit LeuvenLeuvenBelgium

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