EC Approves New Formulation of Celltrion’s Remsima

The European Commission approved Celltrion Healthcare’s subcutaneous formulation of Remsima (infliximab) for treatment of  Crohn’s disease, ulcerative colitis, psoriatic arthritis,  psoriasis and ankylosing spondylitis.

The approval was based on positive results from a clinical trial comparing the subcutaneous and intravenous formulations of the drug in patients with active Crohn’s disease and ulcerative colitis over a 1-year treatment period.

Infliximb is a monoclonal antibody that slows down disease progression by neutralizing tumor necrosis factor-alpha (TNF-a), a common cause of autoimmune diseases.