Therapy Areas: Autoimmune
Celltrion USA submits CT-P47 Biologics License Application to FDA
29 January 2024 -

Celltrion USA, a United States subsidiary of South Korea-based biopharmaceutical company Celltrion, announced on Sunday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its CT-P47, a biosimilar candidate of the reference product ACTEMRA (tocilizumab).

The BLA submission was based on data from the global Phase III clinical trial aimed at assessing the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to the reference product ACTEMRA in subjects with moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to Week 52.

CT-P47 includes the active ingredient tocilizumab and is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist.

The company is seeking approval of CT-P47 in both intravenous and subcutaneous routes of administration.