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CHMP Issues Positive Opinion for New Remsima SC® (Infliximab) Dosing

Jun 6, 2024

On 6 June 2024, the Korea Biomedical Review reported that Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for an additional dosing regimen and dose increase for RemsimaSC® (infliximab).   

The new dosing regimen involves three additional IV doses for CD and UC patients commencing at week 10 of IV dosing.  The dose increase provides for as-needed escalation to 240 mg of RemsimaSC® maintenance therapy in CD patients and escalation in patients who have experienced decreased efficacy following 120mg of RemsimaSC®.   

RemsimaSC® has been approved in Europe since 2013.  In February 2024, Celltrion launched RemsimaSC® as Zymfentra® in the US