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.