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.