Celltrion USA, a United States subsidiary of South Korean biopharmaceutical company Celltrion, announced on Sunday that it has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable biosimilar candidate to XOLAIR (omalizumab) to the US Food and Drug Administration (FDA).

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, the company revealed 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, including asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) and CSU.

Thomas Nusbickel, Celltrion USA chief commercial officer, said, '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. We will continue to build upon our strong track record of developing and manufacturing high-quality biosimilars to help improve the lives of patients.'