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# Celltrion Submits BLA for Novel Infliximab Formula
- URL: https://www.fdaweb.com/celltrion-submits-bla-for-novel-infliximab-formula/
- Published: 2022-12-11T12:00:00.000Z
- Updated: 2026-09-14T18:09:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153426

Celltrion USA says it has submitted to FDA a BLA for its CT-P13, a novel subcutaneous formulation of infliximab to be used as maintenance therapy in patients with moderately to severely active ulcerative colitis and Crohn’s disease. A company [statement](https://celltrionhealthcare.com/board/en%5Fnewslist/97?ref=fdaweb.com) says CT-P13 is the only infliximab to have both intravenous and subcutaneous formulations.

The company says the submission was based on data from a Phase 3 pivotal trial that evaluated the formulation’s safety and efficacy for its intended use. “Based on the results of the LIBERTY-UC and LIBERTY-CD studies,” it says, “CT-P13 subcutaneous demonstrated superiority over placebo in maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with ulcerative colitis and Crohn’s disease respectively, over a one-year treatment period.”