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Path to approval proves rocky for copycat biodrugs

Attempts to copy the first generation of biotechnology drugs are facing fierce resistance, as Meredith Wadman reports.

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European Medicine’s Agency (EMEA), guidelines on biosimilars

Datamonitor report on biogenerics

Generic Pharmaceutical Association

Ram Sasisekharan, professor of biological engineering at MIT

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Wadman, M. Path to approval proves rocky for copycat biodrugs. Nature 438, 154–155 (2005). https://doi.org/10.1038/438154a

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