Biosimilar Labeling Variation From Reference Product OK, FDA Says
Executive Summary
A biosimilar that is not licensed for all of the indications on a reference product's label may still need to include some information about that off-label indication to ensure safe use, draft guidance says.
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Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors
Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.