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.
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“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.
US FDA user fee date for privately held company’s 351(k) application referencing Amgen’s Neupogen may have passed without word of a regulatory action; Amgen sued Adello in March alleging infringement of 17 patents covering the innovator product.