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

14 Mar 2018

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.

Sandoz Inc.'s patent litigation-driven request to remove two indications from the US labeling of Erelzi (etanercept-szzs) forced FDA to consider how best to carve out previously approved uses for a biosimilar.

While FDA approved the deletion of claims, and some related clinical information, for psoriatic arthritis (PsA) and plaque psoriasis (PsO) for Erelzi, a biosimilar to Amgen Inc

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

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