FDA Knows Its Own Strength—and It Includes Concentration
FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” FDA thus disagrees that such differences are not clinically meaningful.
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