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Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review

Executive Summary

Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.

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