The US Food and Drug Administration has recommended that the prescribing information for all biosimilar drugs marketed in the country display a uniform biosimilarity statement, including interchangeable biosimilars which currently display an interchangeability statement instead.
Key takeaways:
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Product labeling for biosimilars in the US currently states whether the product “is biosimilar to” or “is interchangeable to” the reference drug.
The agency floated removing interchangeability designation from biosimilar labels as part of draft guidance in September. (Also see "From...