Celltrion Submits BLA for Subcutaneous Infliximab for Inflammatory Bowel Disease

Celltrion has submitted a biologics license application (BLA) to the FDA for CT-P13, a subcutaneous formulation of infliximab, for treatment of inflammatory bowel disease.

The formulation “has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration,” the company said.

The BLA submission is supported by positive data from a phase 3 study evaluating the drug candidate as maintenance therapy in participants with moderate-to-severe ulcerative colitis and Crohn’s disease. Subcutaneous CT-P13 showed superiority over placebo as a maintenance therapy.

Infliximab’s intravenous form, known as Inflectra (infliximab-dyyb) in the U.S. and Remsima in the EU, is approved by the FDA and the EMA.