Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly pretending they are?

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq

Abstract:The US Health and Human Services and the US Food and Drug Administration’s new initiative to ‘genericize’ biosimilars by fast-tracking approvals and eliminating key clinical and switching studies represents a radical departure from established global regulatory science. This policy dismisses the foundational distinction between complex biologicals and simple generic drugs—a distinction unanimously upheld by international regulators like the European […]

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