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FDA Approves Phase III RA Clinical Trial for Celltrion’s Zymfentra™ (SC Infliximab)

Aug 19, 2024

Celltrion announced on 19 August 2024 that the FDA has approved a phase 3 clinical trial of Zymfentra™ (CT-P13 SC, infliximab SC) for rheumatoid arthritis (RA).

In October 2023, Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA, for ulcerative colitis and Crohn’s disease.  Celltrion launched Zymfentra™ in the US in March 2024.

Zymfentra™ is known as Remsima SC® in Europe.  Remsima SC® has been approved in Europe since 2013.