Subscribe to Journal
Get full journal access for 1 year
only $20.83 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Rent or Buy article
Get time limited or full article access on ReadCube.
All prices are NET prices.
Regulation (EC) 726/2004 of the European Parliament and of the Council. Official J. EU L136/1–L136/33 (2004).
Committee for Medicinal Products for Human Use. Biosimilar Guidelines (accessed 20 July 2011); http://www.ema.europa.eu/htms/human/humanguidelines/multidiscipline.htm
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
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
Chirino, A.J. & Mire-Sluis, A. Nat. Biotechnol. 22, 1383–1391 (2004).
Schellekens, H. NDT Plus 2 (suppl. 1), i27–i36 (2009).
Brockmeyer, C. & Seidl, A. EJHPPract. 15, 38–44 (2009).
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
Combe, C., Tredree, R.L. & Schellekens, H. Pharmacotherapy 25, 954–962 (2005).
Schmidt, C.A., Ramos, A.S., da Silva, J.E.P., Fronza, M. & Dalmora, S.L. Arq. Bras. Endocrinol. Metabol. 47, 183–189 (2003).
Keithi-Reddy, S.R., Kandasamy, S. & Singh, A.K. Kidney Int. 74, 1617–1622 (2008).
Gray, E. & Mulloy, B. J. Thromb. Haemost. 7, 1218–1221 (2009).
Wenzel, R.G. Am. J. Health Syst. Pharm. 65 (suppl. 6), S9–S15 (2008).
World Health Organization. General information on counterfeit medicines (accessed 20 July 2011) http://www.who.int/medicines/services/counterfeit/overview/en/
Fotiou, F., Aravind, S., Wang, P.P. & Nerapusee, O. Clin. Ther. 31, 336–346 (2009).
Anonymous. Aids Alert 18, 79–80 (2003).
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.
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
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
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.
The authors declare no competing financial interests.
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
British Journal of Ophthalmology (2020)
Quantitative comparison of the N-glycosylation of therapeutic glycoproteins using the Glycosimilarity Index. A tutorial
TrAC Trends in Analytical Chemistry (2020)
Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing
International Journal of Clinical Pharmacy (2019)