Posted by Michael Wonder on 24 Dec 2022
Celltrion USA announces submission of the biologics license application of novel subcutaneous formulation of CT-P13 to US FDA
22 December 2022 - CT-P13 SC is a novel subcutaneous formulation of infliximab.
Celltrion USA today announced the submission of a biologics license application under the 351 (a) pathway of the Public Health Service Act for lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab to the US FDA.
The planned initial submission package will seek approval of CT-P13 SC for the treatment of inflammatory bowel disease.
