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Toward biosimilar monoclonal antibodies

Nature Biotechnology volume 26, pages 985–990 (2008)Cite this article

To what extent is the existing framework for biosimilars in Europe likely to be applicable to monoclonal antibodies?

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Acknowledgements

We thank Pekka Kurki from the National Agency for Medicines, Helsinki, Finland, who is the former BMWP chairman and one of the founders of the 'biosimilars framework' of the EU, for helpful discussion. We also wish to thank Martina Weise from the German Federal Institute for Drugs and Medical Devices, who is the vice-chair of the BMWP, for very helpful comments.

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Authors and Affiliations

  1. the Chairman of the BMWP and as a member of the SAWP. He is also in the Division EU-Cooperation/Microbiology at the Paul-Ehrlich-Institut, Christian K. Schneider is at the EMEA as a member of the CHMP, Federal Agency for Sera and Vaccines, Paul-Ehrlich-Strasse 51-59, D-63225 Langen, Germany.,

    Christian K Schneider

  2. Ulrich Kalinke is in the Division of Immunology, Paul-Ehrlich-Institut, and at the Twincore Center for Experimental and Clinical Infection Research, Feodor-Lynen-Str. 7, 30625 Hannover, Germany. kalul@pei.de schci@pei.de,

    Ulrich Kalinke

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  1. Christian K Schneider
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  2. Ulrich Kalinke
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Schneider, C., Kalinke, U. Toward biosimilar monoclonal antibodies. Nat Biotechnol 26, 985–990 (2008). https://doi.org/10.1038/nbt0908-985

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