Biosimilar Legal Landscape: Lessons From 2017
In several firsts last year, US Supreme Court ruled on BPCIA, Amgen won a damages award in infringement litigation, and Amgen and Mylan inked deals clearing way for future launch of Humira and Herceptin biosimilars. Chart includes status of 15 cases and questions teed up for courts to tackle in 2018.
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US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'
Ixifi (infliximab-qbtx), which references Janssen's Remicade, marks first US approval of a biosimilar developed entirely by Pfizer; big pharma says it is not currently planning to launch Ixifi because it remains "committed" to marketing Celltrion's Inflectra.
The latest drug development news and highlights from our US FDA Performance Tracker.