Celltrion USA files for FDA approval of SC biosimilar infliximab

South Korea’s Celltrion Healthcare (Kosdaq: 068270) has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for its lead product candidate, CT-P13 SC (also known as Remsima), which is the subcutaneous formulation of infliximab, to the US Food and Drug Administration (FDA).

Infliximab is marketed as Remicade by Johnson & Johnson (NYSE: JNJ) subsidiary Janssen, and generated global sales of $558 million in third-quarter 2022. The planned initial submission package will seek approval of CT-P13 SC for the treatment of inflammatory bowel disease (IBD).

“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 chief executive of Celltrion Healthcare, who added: “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.”