Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Correspondence
  • Published:

In support of the European Union biosimilar framework

Nature Biotechnology volume 30, pages 745–748 (2012)Cite this article

Subjects

To the Editor:

The commentary by Schellekens and Moors1 on clinical comparability and the European biosimilar regulations in a previous issue questions the value of the comparability exercise mandated in the European Union (EU; Brussels) regulatory guidance. Their argument is based for the most part on the assertion that the comparability exercise is superseded by clinical data. Schellekens and Moors claim not only that requiring a comparability assessment of a biosimilar with a brand-name product will inhibit the development of complex biologicals as biosimilars where (nonrelevant) differences are often anticipated, but also that the biosimilar framework should be extended to cover complex nonbiological products. Conversely, we propose that data on both analytical comparability and clinical comparability are needed to facilitate the proper development of biosimilars. Although we welcome Schellekens and Moors' comments as part of the ongoing debate concerning biosimilar regulatory oversight, we nonetheless consider their arguments misleading—even incorrect—from a scientific perspective. In the following article, we respond from quality (chemistry manufacturing and controls, CMC), nonclinical and clinical points of view.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Schellekens, H. & Moors, E. Clinical comparability and European biosimilar regulations. Nat. Biotechnol. 28, 28–31 (2010).

    Article  CAS  Google Scholar 

  2. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues CHMP/BWP/49348/05 (2006). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf

  3. European Medicines Agency. Refusal assessment report for Alpheon. (2007). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000585/WC500070792.pdf

  4. European Medicines Agency. Multidisciplinary guidelines: biosimilar. (2012). http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c

  5. Schneider, C.K. & Kalinke, U. Toward biosimilar monoclonal antibodies. Nat. Biotechnol. 26, 985–990 (2008).

    Article  CAS  Google Scholar 

  6. European Medicines Agency. Guidance on similar medicinal products containing recombinant human soluble insulin EMEA/CHMP/BMWP/32775/2005 (2006). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003957.pdf

  7. European Medicines Agency. Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor EMEA/CHMP/BMWP/31329/2005 (2006). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003955.pdf

  8. European Medicines Agency. Guideline on similar biological medicinal products containing interferon beta EMA/CHMP/BMWP/652000/2010 (2011). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/01/WC500120652.pdf

  9. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies -- non-clinical and clinical issues EMA/CHMP/BMWP/403543/2010 (2012). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf

  10. European Medicines Agency. Guideline on similar biological medicinal products CHMP/437/04 (2005). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf

  11. European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins EMEA/CHMP/BMWP/118264/2007 (2009). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003927.pdf

  12. European Medicines Agency. Concept Paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies EMEA/CHMP/BMWP/632613/2009 (2009). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/11/WC500014438.pdf

  13. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf

  14. European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (revision) EMEA/CHMP/BMWP/301636/2008 corr (2010). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089474.pdf

  15. European Medicines Agency. Concept paper on the revision of the guideline on similar biological medicinal product EMA/CHMP/BMWP/572643/2011 (2011). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500117987.pdf

  16. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) EMA/CHMP/BWP/247713/2012 (2012). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf

  17. European Medicines Agency. Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues EMA/CHMP/BMWP/572828/2011 (2011). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/10/WC500115611.pdf

Download references

Author information

Authors and Affiliations

  1. Danish Health and Medicines Authority, Copenhagen, Denmark

    Christian K Schneider

  2. Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany

    Christian K Schneider

  3. Medicines Authority, Gzira, Malta

    John J Borg

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

    Falk Ehmann, Klara Tiitso & Camille Vleminckx

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

    Niklas Ekman & Esa Heinonen

  6. Swissmedic, Bern, Switzerland

    Esa Heinonen

  7. Agence nationale de securité du médicament et des produits de santé (ANSM), Paris, France

    Kowid Ho & Jean-Hugues Trouvin

  8. Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands

    Marcel H Hoefnagel, Roeland Martijn van der Plas & Antonius J van der Stappen

  9. Spanish Medicines Agency (AEMPS), Madrid, Spain

    Sol Ruiz

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

    Robin Thorpe

  11. Aristotle University of Thessaloniki, Thessaloniki, Greece

    Asterios S Tsiftsoglou

  12. Austrian Medicines and Medical Devices Agency (AGES), Vienna, Austria

    Guenter Waxenecker

  13. Medical Products Agency (MPA), Uppsala, Sweden

    Mats Welin

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

    Martina Weise

  15. University Paris Descartes, Paris, France

    Jean-Hugues Trouvin

Authors
  1. Christian K Schneider
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. John J Borg
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Falk Ehmann
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Niklas Ekman
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Esa Heinonen
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Kowid Ho
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Marcel H Hoefnagel
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Roeland Martijn van der Plas
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Sol Ruiz
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Antonius J van der Stappen
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Robin Thorpe
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Klara Tiitso
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Asterios S Tsiftsoglou
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Camille Vleminckx
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Guenter Waxenecker
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Mats Welin
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Martina Weise
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. Jean-Hugues Trouvin
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP)

Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP)

Corresponding author

Correspondence to Christian K Schneider.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Schneider, C., Borg, J., Ehmann, F. et al. In support of the European Union biosimilar framework. Nat Biotechnol 30, 745–748 (2012). https://doi.org/10.1038/nbt.2322

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt.2322

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research