메뉴 건너뛰기




Volumn 30, Issue 12, 2007, Pages 1087-1092

Biotherapeutics in the era of biosimilars: What really matters is patient safety

Author keywords

Biotherapies; Generic substitution; Regulatory process

Indexed keywords

ABSEAMED; ALPHEON; BINOCRIT; EPOETIN ALFA HEXAL; ERYTHROPOIETIN ALPHA; HUMAN GROWTH HORMONE; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG; VALTROPIN;

EID: 36448974120     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730120-00002     Document Type: Note
Times cited : (28)

References (12)
  • 1
    • 36448961334 scopus 로고    scopus 로고
    • WHO, Geneva: WHO [online, Available from URL:, Accessed Oct 8
    • WHO. International nonproprietary names. Geneva: WHO [online]. Available from URL: http://www.who.int/medicines/services/inn/en/ [Accessed 2007 Oct 8]
    • (2007) International nonproprietary names
  • 2
    • 36448930623 scopus 로고    scopus 로고
    • Guidance on INN. Geneva: WHO [online]. Available from URL: http://www.who.int/medicines/services/inn/innguidance/en/index.html [Accessed 2007 Nov 1]
    • 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
    • 36448937912 scopus 로고    scopus 로고
    • EMEA guidelines on similar biological medicinal products. London: EMEA, 2005. Document no.: EMEA/CHMP/437/04
    • EMEA guidelines on similar biological medicinal products. London: EMEA, 2005. Document no.: EMEA/CHMP/437/04
  • 4
    • 36448931728 scopus 로고    scopus 로고
    • 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]
    • 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
    • 36448974616 scopus 로고    scopus 로고
    • 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]
    • 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]
  • 6
    • 36448954012 scopus 로고    scopus 로고
    • 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]
    • 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
    • 36448997491 scopus 로고    scopus 로고
    • 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]
    • 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
    • 19044395847 scopus 로고    scopus 로고
    • Follow-on biologics: Challenges of the 'next generation'. Nephrol
    • Schellekens H. Follow-on biologics: challenges of the 'next generation'. Nephrol Dial Transplant 2005; 20 Suppl. 4: 31-6
    • (2005) Dial Transplant , vol.20 , Issue.SUPPL. 4 , pp. 31-36
    • Schellekens, H.1
  • 9
    • 36448975938 scopus 로고    scopus 로고
    • Projet de loi portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament. Legifrance [online]. Available from URL: http://www.legifrance.gouv.fr/html/actualite/ actualite_legislative/exp_ddac_medicament.htm [Accessed 2007 Nov 1]
    • Projet de loi portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament. Legifrance [online]. Available from URL: http://www.legifrance.gouv.fr/html/actualite/ actualite_legislative/exp_ddac_medicament.htm [Accessed 2007 Nov 1]
  • 10
    • 36448935781 scopus 로고    scopus 로고
    • 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]
    • 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
    • 36448946280 scopus 로고    scopus 로고
    • 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 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
    • 36448932098 scopus 로고    scopus 로고
    • European Biopharmaceutical Enterprises EBE, online, Available from URL:, Accessed Nov 1
    • 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]
    • (2006) naming of biotech medicines including biosimilars: WHO meeting positive for innovator industry. EBE


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.