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# FDA Panel Backs Remicade Biosimilar Product
- URL: https://www.fdaweb.com/fda-panel-backs-remicade-biosimilar-product/
- Published: 2016-02-10T12:00:00.000Z
- Updated: 2026-09-15T02:34:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134733

> FDA’s Arthritis Advisory Committee has voted 21 to 3 to support the approval of Celltrion’s proposed biosimilar CT-P13 after finding it highly similar to Janssen’s Remicade (infliximab). Panel members agreed with agency reviewers’ assessment that CT-P13 was highly similar, notwithstanding minor differences in clinically inactive components. “Review of an extensive battery of test results provided by Celltrion confirmed the relevance of comparative clinical and non-clinical data with EU-approved Remicade to support conclusions of biosimilarity to U.S.-licensed Remicade,” the reviewers noted in briefing documents released before the panel meeting.  
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> Celltrion used a non-U.S.-licensed comparator (European Union-approved Remicade) in some studies intended to support a demonstration of biosimilarity to the U.S.-licensed reference product. “Accordingly, Celltrion was required to scientifically justify the relevance of that data by establishing an adequate scientific bridge between EU-approved Remicade, the U.S.-licensed reference product and CT-P13,” the agency said.  
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> Panel members agreed that there is adequate evidence to extrapolate data from the clinical studies to support a determination of biosimilarity of CT-P13 for all indications for which Remicade is licensed — Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis, and adult and pediatric Crohn’s disease.