Celltrion Submits BLA for New Formulation of Infliximab

Celltrion USA has submitted to the FDA a biologics license application (BLA) for lead product candidate, CT-P13 SC, which is a subcutaneous formulation of infliximab to be used a maintenance therapy for patients with inflammatory bowel disease (IBD). If approved, this would be the first subcutaneous formulation of infliximab.

A subcutaneous 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. “CT-P13 SC releases the burden of having to travel to treatment for IV infusions, reducing treatment-related travel costs for patients and caregivers,” Jaeik Shim, chief operating officer of Celltrion USA, said in a press release.

Celltrion was the first company to develop a biosimilar of Janssen’s Remicade (infliximab). The FDA approved Inflectra (infliximab-dyyb) in April 2016 to treat patients with several conditions, including Crohn’s, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Both Remicade and Inflectra are administered by intravenous infusion.

The submission of CT-P13 SC is based on results from the phase 3 pivotal data that evaluated the efficacy and safety of CT-P13 SC as maintenance therapy in patients with moderate to severe active ulcerative colitis (UC) (LIBERTY-UC) and Crohn’s disease (CD) (LIBERTY-CD).

Based on the results of these studies, CT-P13 SC demonstrated superiority over placebo in maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD respectively, over a one-year treatment period.

Another study, REMSWITCH, investigated the clinical and pharmacological impact of switching from IV to SC formulation of infliximab in patients with IBD. Results showed switching patients from IV to SC infliximab is feasible, well-accepted and leads to a low risk of relapse in patients.

Additionally, a post-hoc analysis of a pivotal phase 3 trial shows that the subcutaneous formulation of infliximab is associated with significantly greater improvements in clinical outcomes compared with the intravenous formulation of infliximab at week 30, in patients with rheumatoid arthritis. Between-group differences were reduced at week 54, suggesting improved responses after switching.