The devolution of biosimilars regulations
Publication date
2025
Authors
Doevendans, Erik
van Meer, Peter
Schellekens, Huub
Editors
Advisors
Supervisors
Document Type
Comment
Metadata
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License
taverne
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.
Keywords
Taverne, Biotechnology, Bioengineering, Applied Microbiology and Biotechnology, Molecular Medicine, Biomedical Engineering
Citation
Doevendans, E, van Meer, P & Schellekens, H 2025, 'The devolution of biosimilars regulations', Nature Biotechnology, vol. 43, no. 1, pp. 19-22. https://doi.org/10.1038/s41587-024-02497-5