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Janssen sues Amgen over Stelara® (ustekinumab) biosimilar

Nov 30, 2022

Janssen sued Amgen in the District Court of Delaware in relation to Amgen’s ABP654 (biosimilar ustekinumab).  Janssen alleges that Amgen’s product will infringe US patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis).  Amgen released preliminary results from its Ph III trials of ABP654 in April 2022, and it has not yet been approved by the FDA.