Celltrion USA completes submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an interchangeable biosimilar candidate of XOLAIR® (omalizumab)

• The BLA for CT-P39 was based on totality of evidence including results from Phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR^® (omalizumab) in patients with chronic spontaneous urticaria

JERSEY CITY, N.J., March 10, 2024 /PRNewswire/ -- Celltrion USA today announced that the company has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable biosimilar candidate to XOLAIR^® (omalizumab) to the U.S. Food and Drug Administration (FDA).^[1]

"We are pleased with the rapid progress made in the development of CT-P39, and we look forward to expanding our portfolio beyond immunology and oncology," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We will continue to build upon our strong track record of developing and manufacturing high-quality biosimilars to help improve the lives of patients."

The BLA submission includes results from a global Phase III clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of CT-P39 compared to the reference product XOLAIR® in patients with chronic spontaneous urticaria (CSU) up to Week 40. In November 2023, Celltrion presented the primary results of its 12-week clinical trial during the American College of Allergy, Asthma and Immunology (ACAAI) conference in Anaheim, California.

The Celltrion USA application for CT-P39 includes all the indications for which XOLAIR®, an injectable biologic medicine, is approved for, including asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) and CSU. 

According to IQVIA, a drug market research company, XOLAIR® achieved global market sales of $3.89 billion in 2022,^[2] with its compound patent already expired and its formulation patent set to expire in November 2025 in the U.S.

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

[1] XOLAIR® is a registered trademark of Genentech, Inc and Novartis Pharmaceuticals Corporation.
[2] IQVIA, 2022

US-CT-P39-24-00001 02/24

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SOURCE Celltrion USA