The devolution of biosimilars regulations
Nature Biotechnology, Published online: 16 December 2024; doi:10.1038/s41587-024-02497-5After 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…
Nature Biotechnology, Published online: 16 December 2024; doi:10.1038/s41587-024-02497-5After 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…
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