Celltrion

US Food and Drug Administration

First subcutaneous formulation of infliximab submitted to FDA

4 January 2023

Celltrion USA has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for CT-P13 SC for the treatment of inflammatory bowel disease (IBD).  The submission is based on results from the Phase III pivotal data that evaluated the efficacy and safety of CT-P13 SC as maintenance therapy […]