FDA reverses, plans to pull interchangeability statement from labels of interchangeable biosimilars
The FDA on Friday released new draft guidance that reverses prior guidance and says that interchangeable biosimilars should no longer include a description of their designation on their labels.
The agency said it’s making the move as an explanation of the interchangeability standard in the label “is not likely to be useful to prescribers, who can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products.”
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