Biosimilars—why terminology matters

Subjects

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1

    Regulation (EC) 726/2004 of the European Parliament and of the Council. Official J. EU L136/1–L136/33 (2004).

  2. 2

    Committee for Medicinal Products for Human Use. Biosimilar Guidelines (accessed 20 July 2011); http://www.ema.europa.eu/htms/human/humanguidelines/multidiscipline.htm

  3. 3

    European Commission. Directive 2001/83/EC Art. 10(4) and Part II of the Annex I of Directive 2001/83/EC, as amended. EudraLex, Volume 1, Pharmaceutical legislation medicinal products for human use (accessed 20 July 2011); http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf

  4. 4

    European Medicines Agency. Guideline on Comparability of Biotechnology-Derived Medicinal Products After a Change in the Manufacturing Process: Non-Clinical and Clinical Issues EMEA/CHMP/BMWP/101695/2006 (EMA, London, 19 July 2007; accessed 20 July 2011) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003935.pdf

  5. 5

    Chirino, A.J. & Mire-Sluis, A. Nat. Biotechnol. 22, 1383–1391 (2004).

  6. 6

    Schellekens, H. NDT Plus 2 (suppl. 1), i27–i36 (2009).

  7. 7

    Brockmeyer, C. & Seidl, A. EJHPPract. 15, 38–44 (2009).

  8. 8

    European Medicines Agency. EPARs for authorised medicinal products for human use (accessed 20 July 2011); http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125

  9. 9

    Combe, C., Tredree, R.L. & Schellekens, H. Pharmacotherapy 25, 954–962 (2005).

  10. 10

    Schmidt, C.A., Ramos, A.S., da Silva, J.E.P., Fronza, M. & Dalmora, S.L. Arq. Bras. Endocrinol. Metabol. 47, 183–189 (2003).

  11. 11

    Keithi-Reddy, S.R., Kandasamy, S. & Singh, A.K. Kidney Int. 74, 1617–1622 (2008).

  12. 12

    Gray, E. & Mulloy, B. J. Thromb. Haemost. 7, 1218–1221 (2009).

  13. 13

    Wenzel, R.G. Am. J. Health Syst. Pharm. 65 (suppl. 6), S9–S15 (2008).

  14. 14

    World Health Organization. General information on counterfeit medicines (accessed 20 July 2011) http://www.who.int/medicines/services/counterfeit/overview/en/

  15. 15

    Fotiou, F., Aravind, S., Wang, P.P. & Nerapusee, O. Clin. Ther. 31, 336–346 (2009).

  16. 16

    Anonymous. Aids Alert 18, 79–80 (2003).

  17. 17

    World Health Organization. Expert Committee on Biological Standardization. Guidelines on Evaluation of Similar Biotherapeutic Products (WHO, Geneva, 2009; accessed 20 July 2011) http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.

  18. 18

    Federal Drug Administration. Follow-on protein products: regulatory and scientific issues related to developing (accessed 31 May 2011) http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm085854.htm

  19. 19

    Patient Protection and Affordable Care Act, as amended by the 111th Congress, H.R. 3590 (accessed 20 July 2011). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h3590enr.txt.pdf

Download references

Acknowledgements

The authors wish to thank colleagues from the Biologicals Working Party (BWP), in particular its Chairman, J.-H. Trouvin, for valuable comments on the manuscript.

Author information

Correspondence to Martina Weise.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Weise, M., Bielsky, M., De Smet, K. et al. Biosimilars—why terminology matters. Nat Biotechnol 29, 690–693 (2011). https://doi.org/10.1038/nbt.1936

Download citation

Further reading