For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.
Access options
Subscribe to Journal
Get full journal access for 1 year
$259.00
only $21.58 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.
from$8.99
All prices are NET prices.
References
- 1
European Commission. Off. J. Eur. Union L136, 34–57 (2004).
- 2
Health, I.M.S. Shaping the Biosimilars Opportunity: a Global Perspective on the Evolving Biosimilars Landscape (IMS Health, New York, USA, 2011; accessed 11 April 2012). <http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf>
- 3
European Medicines Agency. Volume 9A of The Rules Governing Medicinal Products in the European Union. (EMA, London, 2008; accessed 2 August 2012). <http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf>
- 4
European Commission. Off. J. Eur. Union L311, 67–267 (2001).
- 5
European Medicines Agency. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins (EMA, London, 2007; accessed 3 July 2012). <http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003947.pdf>
- 6
Casadevall, N. et al. N. Engl. J. Med. 346, 469–475 (2002).
- 7
Gascon, P. et al. Ann. Oncol. 21, 1419–1429 (2010).
- 8
European Medicines Agency. EPARs for Authorised Medicinal Products for Human Use (EMA, London; accessed 9 September 2012). http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124
- 9
Frau, S., Font Pous, M., Luppino, M.R. & Conforti, A. Eur. J. Clin. Pharmacol. 66, 785–790 (2010).
- 10
Haag-Weber, M. et al. Clin. Nephrol. 77, 8–17 (2012).
- 11
Seidl, A. et al. Pharm. Res. 29, 1454–1467 (2012).
- 12
Jiang, Y. et al. J. Pharm. Sci. 98, 4695–4710 (2009).
- 13
Praditpornsilpa, K. et al. Kidney Int. 80, 88–92 (2011).
- 14
Peterson, G.M. Br. J. Clin. Pharmacol. 71, 966–967, author reply 968 (2011).
- 15
Meredith, P.A. Curr. Med. Res. Opin. 25, 2179–2189 (2009).
- 16
Walsh, G. Drug Discov. Today 15, 773–780 (2010).
- 17
European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues EMEA/CHMP/BMWP/42832/2005 (EMA, London, 2006; accessed 26 July 2012). <http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf>
- 18
European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (EMA, London, 2006). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf
- 19
Covic, A. et al. Nephrol. Dial. Transplant. 23, 3731–3737 (2008).
- 20
Rovira, J., Espin, J., Garcia, L. & Olry de Labry, A. The Impact of Biosimilars' Entry in the EU Market (Andalusian School of Public Health, Spain, 2011).
- 21
Niederwieser, D. & Schmitz, S. Eur. J. Haematol. 86, 277–288 (2011).
- 22
Minghetti, P., Rocco, P., Del Vecchio, L. & Locatelli, F. Nephron Clin. Pract. 117, c1–c7 (2011).
- 23
Brinks, V. et al. Pharm. Res. 28, 386–393 (2011).
- 24
Storring, P.L. et al. Br. J. Haematol. 100, 79–89 (1998).
- 25
Schiestl, M. et al. Nat. Biotechnol. 29, 310–312 (2011).
- 26
Vanrenterghem, Y. et al. Kidney Int. 62, 2167–2175 (2002).
- 27
Dellanna, F. et al. Int. J. Clin. Pract. 65, 64–72 (2011).
- 28
Ebbers, H.C., Muenzberg, M. & Schellekens, H. Exp. Opin. Biol. Ther. 12, 1473–1485 (2012).
- 29
Duerden, M.G. & Hughes, D.A. Br. J. Clin. Pharmacol. 70, 335–341 (2010).
- 30
Kresse, G.B. Eur. J. Pharm. Biopharm. 72, 479–486 (2009).
- 31
Declerck, P.J. et al. Curr. Med. Res. Opin. 26, 1219–1229 (2010).
- 32
Shankar, G., Pendley, C. & Stein, K.E. Nat. Biotechnol. 25, 555–561 (2007).
- 33
Macdougall, I.C. et al. N. Engl. J. Med. 361, 1848–1855 (2009).
- 34
European Medicines Agency. Scientific Guidance Documents on Biosimilar Medicines (EMA, London; accessed 4 September 2012) <http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002958c&jsenabled=true>
Author information
Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no conflict of interest relevant to the subject matter or materials discussed in the manuscript. No funding was received for the preparation of this article. This study was performed in the context of the Escher project (T6-202), a project of the Dutch Top Institute Pharma. The division of Pharmacoepidemiology and Clinical Pharmacology, where H.C.E. is employed, has received unrestricted funding for pharmaco-epidemiological research from GlaxoSmithKline, the private-public funded Top Institute Pharma (http://www.tipharma.nl, includes co-funding from universities, government and industry), the Dutch Medicines Evaluation Board and the Dutch Ministry of Health. H.S. participated in meetings and publications sponsored by Amgen, Johnson & Johnson, Roche, Sandoz and Hospira. Part of his research is directly or indirectly sponsored by Roche, Amgen and Sandoz.
Rights and permissions
About this article
Cite this article
Ebbers, H., Crow, S., Vulto, A. et al. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 30, 1186–1190 (2012). https://doi.org/10.1038/nbt.2438
Published:
Issue Date:
Further reading
-
Switching from originator recombinant growth hormone (Genotropin™) to biosimilar (CRISCY™): Results from a 6-month, multicentric, non-inferiority, extension trial.
Growth Hormone & IGF Research (2021)
-
Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences
Journal of Pharmaceutical Sciences (2020)
-
The road to biosimilars in rare diseases ‐ ongoing lessons from Gaucher disease
American Journal of Hematology (2020)
-
Report on the Second PANLAR Review Course in Rheumatology
JCR: Journal of Clinical Rheumatology (2020)
-
Interlaboratory Study for Characterizing Monoclonal Antibodies by Top-Down and Middle-Down Mass Spectrometry
Journal of the American Society for Mass Spectrometry (2020)