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Setting the stage for biosimilar monoclonal antibodies

Nature Biotechnology volume 30, pages1179–1185(2012)Cite this article

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With the first marketing authorization application for a biosimilar monoclonal antibody now under consideration at the European Medicines Agency, what are the critical issues for regulators?

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Figure 1: Regulatory history of biosimilar mAbs in Europe.
Figure 2: Regulatory issues and market uptake for biosimilars in the EU.

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Acknowledgements

The authors wish to thank P. Richardson from the EMA for providing the regulatory description of dossier requirements for biosimilars that we used for Figure 2a, D. Mannion from the Danish Health and Medicines Authority for helpful comments on the manuscript, and K. Desser from the Danish Health and Medicines Authority for providing the figures from the Danish Register of Medicinal Products Statistics. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.

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Affiliations

  1. Christian K. Schneider is at the Danish Health and Medicines Authority, Copenhagen, Denmark, the Working Party on Biosimilar Medicinal Products, European Medicines Agency (EMA), London, UK, and the Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany.

    Christian K Schneider

  2. Camille Vleminckx, Iordanis Gravanis and Falk Ehmann are at the EMA, London, UK.

    Camille Vleminckx, Iordanis Gravanis & Falk Ehmann

  3. Jean-Hugues Trouvin is at the Biologicals Working Party, EMA, London, and the School of Pharmacy, Paris Descartes University, Paris, France.

    Jean-Hugues Trouvin

  4. Martina Weise is at the Working Party on Biosimilar Medicinal Products, EMA, London, UK, and the Bundesinstitut fuer Arzneimittel und Medizinprodukte, Bonn, Germany.

    Martina Weise

  5. Steffen Thirstrup is at the Danish Health and Medicines Authority, Copenhagen, Denmark, and the European Commission Project Group on Access and Uptake of Biosimilars and Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark.

    Steffen Thirstrup

Authors
  1. Christian K Schneider
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  2. Camille Vleminckx
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  3. Iordanis Gravanis
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  4. Falk Ehmann
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  5. Jean-Hugues Trouvin
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  6. Martina Weise
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  7. Steffen Thirstrup
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Corresponding author

Correspondence to Christian K Schneider.

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The authors declare no competing financial interests.

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Schneider, C., Vleminckx, C., Gravanis, I. et al. Setting the stage for biosimilar monoclonal antibodies. Nat Biotechnol 30, 1179–1185 (2012). https://doi.org/10.1038/nbt.2447

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