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

11 Mar 2024
Phase 3Clinical ResultDrug Approval
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.
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.
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion that may constitute forward-looking statements under pertinent securities laws.
These statements may be identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion's management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
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Such risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
[1] XOLAIR® is a registered trademark of Genentech, Inc and Novartis Pharmaceuticals Corporation.
[2] IQVIA, 2022
US-CT-P39-24-00001 02/24
Sarah Amundsen
+1 920-946-0918
SOURCE Celltrion USA
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