Celltrion USA 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).
"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.
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