• The approval follows the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis- evaluating its PK- efficacy- and safety
• The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment time to approximately 2-5 minutes
• Remsima is a world’s first mAb indicated to treat eight autoimmune diseases including RA & IBD and approved in the US & EU with Inflectra & Remsima respectively. Till now the product is approved in 94 countries including the US- Canada- Japan and throughout EU

Ref: Celltrion | Image: Celltrion