Ever since its introduction, the US Food and Drug Administration’s interchangeability designation for biosimilars has been a much-debated topic among industry stakeholders. But now, the latest FDA draft guidance has recommended removing the designation from biosimilar labels altogether.
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New US FDA draft guidance has recommended removing details of interchangeability from biosimilar labels
Citing the difficultly of appropriately labeling interchangeable biosimilars and updating labeling “without causing undue confusion” – as well as suggesting...