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

Executive Summary

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.

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