FDA Accepts Biologics License Application for CT-P13 SC, Novel Subcutaneous Formulation of Infliximab

Celltrion USA has announced the submission of a Biologics License Application (BLA) to the FDA for a novel subcutaneous (SC) formulation of CT-P13, which is the first and only infliximab biosimilar to have both intravenous (IV) and SC formulations. The new SC formulation provides an alternative administration option.

CT-P13 SC is the first SC formulation of infliximab worldwide. A 120-mg fixed SC dose has been approved for use in the European Union for adults, regardless of body weight, in both existing and newly added indications. The SC formulation could enhance treatment options by providing high consistency in drug exposure and a convenient administration method, according to a press release.

The submission is based on results from pivotal phase 3 data evaluating the efficacy and safety of CT-P13 SC as a maintenance therapy in patients with moderate to severe active ulcerative colitis (LIBERTY-UC) and Crohn disease (LIBERTY-CD). Based on the results of these 2 trials, CT-P13 SC demonstrated superiority over placebo in maintenance therapy after induction therapy with an IV formulation of infliximab over a 1-year treatment period.

“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 Hyoung Ki Kim, vice chairman and CEO with Celltrion Healthcare, in a press release. “We are committed to furthering the advancement of innovative treatments that provide improvements to clinical outcomes and drug pharmacology and reduce patients’ burden on their day-to-day lives.”

The LIBERTY-UC trial is a randomized, placebo-controlled, double-blind, phase 3 study designed to evaluate the superiority of CT-P13 SC in efficacy and safety when used as maintenance therapy in patients with moderate to severe active ulcerative colitis. A total of 438 patients were randomized at week 10 and the rate of clinical remission at week 54 was significantly greater in the treatment arm (43.2%) versus placebo (20.8%).

Similarly, the LIBERTY-CD trial evaluated the superiority of CT-P13 SC during maintenance therapy in patients with moderate to severe active Crohn disease. In this trial, 343 patients were randomized at week 10 and at week 54. The data showed that the clinical remission rate was greater in the SC arm (62.3%) versus the placebo arm (32.1%). The safety profile in both the LIBERTY-UC and LIBERT-CD trials was generally comparable between both arms.

“We’re excited about the potential of CT-P13 SC as it allows patients to have more control of their treatment, providing much better independence and convenience,” said Jaeik Shim, chief operating officer at Celltrion USA, in the press release. “In addition, CT-P13 releases the burden of having to travel to treatment for IV infusions, reducing treatment-related travel costs for patients and caregivers.”

REFERENCE

Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to US Food and Drug Administration. News release. BusinessWire; December 22, 2022. Accessed January 3, 2023. https://www.businesswire.com/news/home/20221221005226/en/Celltrion-USA-announces-submission-of-the-Biologics-License-Application-BLA-of-novel-subcutaneous-formulation-of-CT-P13-to-U.S.-Food-and-Drug-Administration