Celltrion submits application for CT-P13 SC to FDA

Celltrion has announced that it has finalised its submission of a biologics license application for the subcutaneous version of a biosimilar to anti-inflammatory medicine Remicade, to be submitted to the FDA. 

CT-P13 SC, also known as Remsima SC, is the company’s subcutaneous (SC) formulation of the infliximab biosimilar for Johnson & Johnson’s Remicade, which treats rheumatoid arthritis. Remsima SC is the first SC formulation of this biosimilar, which has already gained approvals in approximately 40 countries, including Canada and some in Europe.

The drug’s submission to the FDA follows data from Celltrion’s phase 3 trial, which assessed the efficacy and safety of CT-P13 SC in patients with both ulcerative colitis and Crohn’s disease. The trial included 438 patients with ulcerative colitis and 343 with Crohn’s disease. The drug demonstrated significant superiority over a placebo throughout the year-long treatment.

If approved, the drug is anticipated to increase Celltrion’s share in the tumour necrosis factor inhibitors market, following the company’s introduction of Inflectra, or Remsima 4.

Kim Hyoung-ki Kim, Celltrion Healthcare’s vice chairman and chief executive officer, commented: “This BLA submission marks a significant milestone for Celltrion and we are working with the FDA to bring this innovative treatment to the US market.”

Betsy Goodfellow