Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review
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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Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention
Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.
“We’re not going to wait a decade or more for robust biosimilar competition to emerge,” Commissioner Scott Gottlieb says, noting reference biologic sponsors are repeating some of the delay tactics honed in the small molecule space to keep competition at bay.
Keeping Track: Bristol Tests US FDA’s TMB Tolerance, Celltrion Resubmits Herceptin Biosimilar, Nocdurna Approved At Last
The latest drug development news and highlights from our US FDA Performance Tracker.