Celltrion submits FDA application for CT-P13 SC

Celltrion announced Friday that it completed submission of a biologics license application for subcutaneous version of biosimilar to anti-inflammatory medicine Remicade the US drug regulator.

CT-P13 SC, or Remsima SC, is Celltrion’s subcutaneous formulation of the company’s infliximab biosimilar referencing Johnson & Johnson’s rheumatoid arthritis treatment Remicade. CT-P13 SC is the world’s first SC formulation of biosimilar infliximab, which has earned sales approvals in around 40 countries, including Canada and those in Europe.

Celltrion’s latest application to the US Food and Drug Administration is based on clinical data from the company’s pivotal trial, in which the company tested efficacy and safety of CT-P13 SC in patients with ulcerative colitis and Crohn’s disease.

The phase 3 clinical trial included 438 patients with ulcerative colitis and 343 patients with Crohn’s disease. The company said CT-P13 SC demonstrated superiority over placebo over a one-year treatment period.

If approved, CT-P13 SC is expected to help Celltrion to increase its share in the tumor necrosis factor inhibitors market in the US, in which the company had introduced Inflectra, or Remsima 4.

Celltrion’s sales of Inflectra, or Remsima 4, currently account for some 30 percent of the US market, according to Symphony Health.

An official from Celltrion said that CT-P13 SC, if approved, will be able to yield higher profit margins, compared to Inflectra, as it will be marketed as a new drug in the US.

“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,” said Kim Hyoung-ki Kim, Celltrion Healthcare Vice Chairman & CEO.

Meanwhile, Celltrion has also submitted applications to obtain patents regarding the SC formulation in overseas countries including the US and major European countries to protect related technologies.