FDA Panel OKs Celltrion Biosimilar Of Janssen's Remicade

By Jeff Overley (February 9, 2016, 7:54 PM EST) -- After a grueling debate, an independent panel on Tuesday advised the U.S. Food and Drug Administration to approve Celltrion's copy of Janssen Biotech's blockbuster immunosuppressant Remicade, the latest step forward for the emerging biosimilars industry.

The recommendation came in a 21-3 vote from an FDA advisory committee that met in Silver Spring, Maryland. Panelists agreed that Celltrion's product is "highly similar" to Remicade and deserves approval for all seven of the Remicade indications not protected by market exclusivity. The endorsement was based on research that is less than what's required of new biologics but nonetheless intended to show that the biosimilar...

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