Celltrion has filed a biologics licence application (BLA) with the US Food and Drug Administration (FDA) for a biosimilar candidate to XOLAIR (omalizumab), CT-P39, for chronic spontaneous urticaria (CSU).

The submission is a significant step in bringing an interchangeable biosimilar for CSU treatment to the market.

The BLA is based on evidence including data from a global Phase III clinical trial of CT-P39 compared to the reference therapy XOLAIR.

The study assessed the efficacy, safety and pharmacokinetics of CT-P39 for 40 weeks.

CT-P39 demonstrated an efficacy and safety profile comparable with XOLAIR.

The latest application submitted to the FDA by Celltrion includes all indications for which XOLAIR is currently approved.

An injectable biologic, XOLAIR is indicated to treat chronic rhinosinusitis with nasal polyps, asthma, immunoglobulin E-mediated food allergy and CSU. 

The product's compound patent has expired and its formulation patent is due to expire in November 2025 in the US. This opens opportunities for biosimilars such as CT-P39 to capture market share.

Celltrion USA chief commercial officer Thomas Nusbickel stated: “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.”

Last month, Health Canada approved Celltrion Healthcare Canada’s Remsima SC, a subcutaneous infliximab biosimilar, for treating inflammatory bowel disease as a maintenance therapy.

The approval is backed by positive outcomes from the LIBERTY UC and CD trials over 54 weeks. The therapy is indicated for use in patients with moderately to severely active ulcerative colitis and Crohn’s disease.