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Setting the stage for biosimilar monoclonal antibodies

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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Correspondence to Christian K Schneider.

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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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