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BioWorld - Saturday, July 18, 2026
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Home » Remsima briefing docs suggest FDA comfortable with extrapolation
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Remsima briefing docs suggest FDA comfortable with extrapolation

Feb. 8, 2016
By Marie Powers
FDA briefing documents released Friday morning in advance of Tuesday's Arthritis Advisory Committee Meeting 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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