On 4 July 2024, Celltrion announced that it received final approval from the European Commission for an additional dosing regimen and dose increase for Remsima SC® (infliximab). The approval comes almost a month after the CHMP issued a positive opinion for the new dosing.
As previously reported, the new dosing regimen involves three additional IV doses for CD and UC patients with Remsima SC administered from week 10. The dose increase provides for as-needed escalation to 240 mg of Remsima SC® maintenance therapy in CD patients who have experienced decreased efficacy following 120mg of Remsima SC®.
Remsima SC® has been approved in Europe since 2013. In February 2024, Celltrion launched Remsima SC® as Zymfentra® in the US.