Celltrion USA completes submission of Biologics License Application for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab)

• The Biologics License Application for CT-P47 was based on Phase III data comparing CT-P47 to the reference product ACTEMRA^® (tocilizumab)

JERSEY CITY, N.J., Jan. 28, 2024 /PRNewswire/ -- Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product ACTEMRA^® (tocilizumab)^[1].

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

"The submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We plan to lead the market by establishing a diverse product lineup in the autoimmune disease market in the U.S. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with rheumatoid arthritis as soon as possible."

ACTEMRA^® is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous routes of administration.

About Celltrion USA

Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: www.celltrionusa.com. 

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References 

SOURCE Celltrion USA