Skip to main content
SpringerLink
Log in

Biosimilars: initial excitement gives way to reality

  • From the Analyst's Couch
  • Published:

From Nature Reviews Drug Discovery

View current issue Sign up to alerts

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Figure 1: Global sales of biologic products.
Figure 2: Skills and barriers required to develop biosimilars.
Figure 3: Biosimilar suitability depends on drug class.

References

  1. Schellekens, H. How similar do 'biosimilars' need to be? Nature Biotechnol. 22, 1357–1359 (2004).

    Article  CAS  Google Scholar 

  2. Sheridan, C. First generic biologics finally approved. Nature Rev. Drug Discov. 5, 445 (2006).

    Article  CAS  Google Scholar 

  3. Dove, A. Betting on biogenerics. Nature Biotechnol. 19, 117–120 (2001).

    Article  Google Scholar 

  4. EMEA. Biotech medicines: first biosimilar drug on EU market. European Commission. Press release, [online] (2006).

  5. Sandoz, Inc. Sandoz gets precedent-setting US approval for Omnitrope® as first follow on version of a previously approved recombinant biotechnology drug. Press release, [online] (2006).

  6. EMEA/CHMP. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues, [online] (2005).

  7. EMEA/CHMP. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues http://www.emea.eu.int/pdfs/human/biosimilar/4934805en.pdf (2005).

  8. Ben-Maimon, C. S. & Garnick, R. Biogenerics at the crossroads. Nature Biotechnol. 24, 268–268 (2006)

    Google Scholar 

  9. Griffiths, S. From the analyst's couch: Betting on biogenerics. Nature Rev. Drug Discov. 3, 197–198 (2004)

    Article  CAS  Google Scholar 

  10. Schellekens, H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nature Rev. Drug Discov. 1, 457–462 (2002).

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. part of the Strategic Intelligence team at Datamonitor Healthcare, 108–110 Finchley Road, London, NW3 5JJ, UK

    Mark J. Belsey, Laura M. Harris, Romita R. Das & Joanna Chertkow

Authors
  1. Mark J. Belsey
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Laura M. Harris
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Romita R. Das
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Joanna Chertkow
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Joanna Chertkow.

Related links

Related links

FURTHER INFORMATION

European Medicines Evaluation Agency: Guidelines onbiosimilar medicinal products

Food and Drug Administration: Information on Omnitrope

Rights and permissions

Reprints and permissions

About this article

Cite this article

Belsey, M., Harris, L., Das, R. et al. Biosimilars: initial excitement gives way to reality. Nat Rev Drug Discov 5, 535–536 (2006). https://doi.org/10.1038/nrd2093

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nrd2093

  • Springer Nature Limited

This article is cited by

Search

Navigation