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Biosimilars—why terminology matters

Nature Biotechnology volume 29, pages 690–693 (2011)Cite this article

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References

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

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

    Article  CAS  PubMed  Google Scholar 

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

    Article  CAS  PubMed  PubMed Central  Google Scholar 

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

    Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  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).

    Article  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

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

    Article  CAS  PubMed  Google Scholar 

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

  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. 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. 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

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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.

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Authors and Affiliations

  1. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn, Germany

    Martina Weise & Hans-Karl Heim

  2. Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

    Marie-Christine Bielsky & Gopalan Narayanan

  3. Federal Agency for Medicines and Health Products (FAGG), Brussels, Belgium

    Karen De Smet

  4. European Medicines Agency (EMA), London, UK

    Falk Ehmann & Camille Vleminckx

  5. Finnish Medicines Agency (FIMEA), Helsinki, Finland

    Niklas Ekman & Esa Heinonen

  6. L'Agence française de sécurité sanitaire des produits de santé (Afssaps), Paris, France

    Kowid Ho

  7. National Institute for Biological Standards and Control (NIBSC), Hertfordshire, UK

    Robin Thorpe & Meenu Wadhwa

  8. Paul-Ehrlich-Institut (PEI), Langen, Germany, and Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany

    Christian K Schneider

  9. Member of the Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) of the Committee for Medicinal Products for Human Use (CHMP), EMA, UK

    Martina Weise, Karen De Smet, Hans-Karl Heim & Christian K Schneider

  10. Expert of the BMWP, EMA, UK

    Marie-Christine Bielsky, Niklas Ekman, Gopalan Narayanan, Esa Heinonen, Kowid Ho, Robin Thorpe & Meenu Wadhwa

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  1. Martina Weise
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  13. Christian K Schneider
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Correspondence to Martina Weise.

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The authors declare no competing financial interests.

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Cite this article

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

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