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# Celltrion Biosimilar Headed to Panel on ‘Highly Similar’ Finding
- URL: https://www.fdaweb.com/celltrion-biosimilar-headed-to-panel-on-highly-similar-finding/
- Published: 2016-02-05T12:00:00.000Z
- Updated: 2026-09-15T02:33:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134690

> FDA reviewers have concluded that Celltrion’s proposed biosimilar (CT-P13) is highly similar to Janssen’s Remicade (infliximab), notwithstanding minor differences in clinically inactive components. This finding was summarized in [briefing documents](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM484859.pdf?ref=fdaweb.com) released in advance of a 2/9 advisory committee review on the latest biosimialr product to obtain an agency review. The reviewers noted that there are no clinically meaningful differences between CT-P13 and Remicade in terms of the safety, purity, and potency of the product to support the demonstration that CT-P13 is biosimilar to the US-licensed Remicade as studied in rheumatoid arthritis and ankylosing spondylitis indications.  
>  
> The briefing documents said 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. “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.”