Celltrion USA Announces Submission of BLA for Subcutaneous Infliximab Biosimilar 

On December 22, 2022, Celltrion USA announced that it submitted a Biologics License Application (BLA) for a subcutaneous formulation of infliximab, CT-P13, to the U.S. Food and Drug Administration (FDA).  According to Celltrion, the BLA is based on phase III pivotal data that evaluated the efficacy and safety of CT-P13 as a maintenance therapy in patients with moderately to severely active ulcerative colitis and Crohn’s disease.  Results demonstrated superiority over placebo following induction therapy using an intravenous formulation of infliximab over a one-year treatment period.

Celltrion’s INFLECTRA (CT-P13) was previously approved by FDA on April 5, 2016 as an intravenous formulation.  If Celltrion’s new BLA is approved, CT-P13 would become the first subcutaneous formulation of infliximab available to patients.  Jaeik Shim, Celltrion USA’s CEO, explained that “[Celltrion is] excited about the potential of CT-P13 SC,” noting that it “releases the burden of having to travel to treatment for IV infusions, reducing treatment-related travel costs for patients and caregivers.”