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Celltrion positive phase III results for infliximab biobetter Remsima SC®

Mar 3, 2023

Celltrion Healthcare presented its positive phase III results for its infliximab biobetter Remsima SC® as a sub-cutaneous maintenance therapy for patients with IBD.  Remsima SC® (CT-P13 SC) is Celltrion’s subcutaneous re-formulation of Johnson & Johnson’s infliximab (Remicade®).  

Celltrion’s ABLA for Remsima SC® was filed with FDA on 22 December 2022 for use in ulcerative colitis  and Crohn’s disease.  Remsima SC® has been approved in several other jurisdictions (Europe, Korea and Canada) for treatment of various inflammatory conditions.