Nixed Remicade Patent Clears Way For Pfizer/Celltrion Biosimilar Launch

A Massachusetts court's ruling invalidating a patent on Johnson & Johnson's Remicade (infliximab) appears to clear the way for Pfizer Inc. and Celltrion Inc. to finally launch their FDA-licensed biosimilar Inflectra (infliximab-dyyb). J&J, however, said it plans to appeal and any biosimilar launch would be considered "at risk."

When Johnson & Johnson reported its second-quarter earnings in July, it said its sales guidance for 2016 continued to assume no biosimilar entrants against its blockbuster rheumatoid arthritis and Crohn's disease drug Remicade (infliximab), even in the face of the FDA's April 5 approval of Pfizer Inc.'s and Celltrion Inc.'s Inflectra (infliximab-dyyb).

But a Massachusetts judge's Aug. 17 ruling declaring J&J's '471 patent on Remicade invalid likely has the company and its...

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