Skip to main content
Log in

Reply to In support of the European Union biosimilar framework

  • Correspondence
  • Published:

From Nature Biotechnology

View current issue Submit your manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  1. Schneider, C. et al. Nat. Biotechnol. 30, 744–746 (2012).

    Google Scholar 

  2. Schellekens, H. & Moors, E. Nat. Biotechnol. 28, 28–31 (2010).

    Article  CAS  Google Scholar 

  3. European Medicine Agency. Guideline on similar biological medicinal products containing biotechnology-derived 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).

    Article  CAS  Google Scholar 

  7. Prümmer, O. Biotherapy 10, 15–24 (1997).

    Article  Google Scholar 

  8. Baumann, A. . Curr. Drug Metab. 7, 15–21 (2006).

    Article  CAS  Google Scholar 

  9. Mahmood, I. & Green, M.D. Clin. Pharmacokinet. 44, 331–347 (2005).

    Article  CAS  Google Scholar 

  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).

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Consortia

Corresponding author

Correspondence to Christian K Schneider.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Schneider, C., Borg, J., Ehmann, F. et al. Reply to In support of the European Union biosimilar framework. Nat Biotechnol 30, 748–749 (2012). https://doi.org/10.1038/nbt.2327

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt.2327

  • Springer Nature America, Inc.

This article is cited by

Navigation