Biosimilar Labeling Carve-Out Turned Erelzi's Psoriatic Arthritis, Plaque Psoriasis Uses Into 'Another Indication'

US FDA review documents for first-ever carve-out labeling supplement of a biosimilar reveal how references to Erelzi's deleted uses were replaced with 'another indication(s)' when data could not be separated or was needed to convey safety information.

Hand of carver carving wood
A carve-out can be a beautiful thing.

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