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Remsima briefing docs suggest FDA comfortable with extrapolation

By Marie Powers
News Editor

Friday, February 5, 2016

FDA briefing documents released Friday morning in advance of Tuesday's Arthritis Advisory Committee Meeting (adcom) suggested the agency will go gentle on the biologics license application for CT-P13, Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.) that is approved elsewhere as Remsima (infliximab).

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