Celltrion said it has completed its application to the U.S. FDA for the approval of CT-P39, a biosimilar referencing Xolair (ingredient: omalizumab). 

Xolair was developed by Genentech and Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyposis, and chronic idiopathic urticaria.

A blockbuster product with global sales of approximately $3.9 billion in 2022, the substance patent has already expired and the formulation patent is set to expire in March 2024 in Europe and November 2025 in the U.S.

The application is based on the results of a global phase 3 clinical trial involving 619 patients with chronic spontaneous urticaria, demonstrating CT-P39's efficacy, safety, and immunogenicity comparable to Xolair. 

During the clinical trial, patients were divided into two groups, receiving either 300mg or 150mg doses of CT-P39 or Xolair, with the primary endpoint being the change in the Weekly Itch Severity Score (ISS7) from baseline at 12 weeks.

Celltrion reported that CT-P39 met the pre-defined criteria for equivalence to Xolair, alongside similar safety and immunogenicity profiles.

Ahead of this FDA submission, Celltrion had already applied for approval of CT-P39 in Europe, Canada, and Korea last year. 

Notably, the U.S. application seeks to classify CT-P39 as an interchangeable biosimilar, which could allow for rapid market expansion through substitution prescriptions if approved.

“CT-P39 has the potential to be a 'first mover' as it demonstrates efficacy and equivalence to Xolair in a global phase 3 trial, as well as safety, faster than the competition,” a Celltrion official said. “We will finalize the remaining procedures to speed up the approval process and prepare for market penetration to ensure smooth supply to the market after approval.”