The devolution of biosimilars regulations

Erik Doevendans; Peter van Meer; Huub Schellekens

doi:10.1038/s41587-024-02497-5

The devolution of biosimilars regulations

Erik Doevendans, Peter van Meer, Huub Schellekens^*

^*Corresponding author for this work

Research output: Contribution to journal › Comment/Letter to the editor › Academic › peer-review

Abstract

After two decades of experience with biosimilars, physicochemical and in vitro biological comparison with their reference products appear sufficient to guarantee clinical safety and efficacy. Hence, the regulation of biosimilars has become redundant, and biopharmaceuticals should now be regulated through the generic pathway available for small molecules.

Original language	English
Pages (from-to)	19-22
Number of pages	4
Journal	Nature Biotechnology
Volume	43
Issue number	1
Early online date	16 Dec 2024
DOIs	https://doi.org/10.1038/s41587-024-02497-5
Publication status	Published - 2025

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Publisher Copyright:
© Springer Nature America, Inc. 2024.

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s41587-024-02497-5Final published version, 866 KBLicence: Taverne

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The devolution of biosimilars regulations

Abstract

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