Reply to in support of the European Union biosimilar framework

Nature Biotechnology

Volumn 30, Issue 8, 2012, Pages 748-749

  Schellekens, Huub ^a   Moors, Ellen H M ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; PLANT MEDICINAL PRODUCT;

BIOTECHNOLOGY; ENGINEERING; IMMUNOASSAY; IMMUNOGENICITY; LAW; LETTER; LIFE CYCLE; LYMPHATIC SYSTEM; PRIORITY JOURNAL; PROTEIN BINDING;

EID: 84864885623     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2327     Document Type: Letter

References (11)

1. Schneider, C. et al. Nat. Biotechnol. 30, 744-746 (2012).
2. Schellekens, H. & Moors, E. Nat. Biotechnol. 28, 28-31 (2010).
3. European Medicine Agency. Guideline on similar biological medicinal products containing biotechnologyderived proteins as active substance: quality issues EMEA/CHMP/BWP/49348/2005 (2006). http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500003953.pdf
4. European Medicine Agency. Withdrawal assessment report Marvel insulin (2010). http://www. ema.europa.eu/docs/en-GB/document-library/Application- withdrawal-assessment-report/2010/01/WC500067086.pdf
5. European Medicines Agency. European public assessment report (EPAR) for Alpheon (2007). http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of- opinion-Initial-authorisation/human/000585/WC500017451.pdf
6. Hermeling, S., Jiskoot, W., Crommelin, D., Bornaes, C. & Schellekens, H. Pharm. Res. 22, 847-851 (2005).
7. Prümmer, O. Biotherapy 10, 15-24 (1997).
8. Baumann, A. Curr. Drug Metab. 7, 15-21 (2006).
9. Mahmood, I. & Green, M.D. Clin. Pharmacokinet. 44, 331-347 (2005).
10. European Medicine Agency. European public assessment report Avonex (2006). http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Scientific- Discussion/human/000102/WC500029420.pdf
11. Alam, J. et al. Pharm. Res. 14, 546-549 (1997).