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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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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DOI: https://doi.org/10.1038/nbt0908-985