Celltrion announced on March 11 that it has submitted a marketing authorization application to the U.S. Food and Drug Administration (FDA) for CT-P39, a biosimilar to XOLAIR (omalizumab), for the treatment of asthma and chronic spontaneous urticaria.
Based on the results of a global Phase 3 clinical trial of CT-P39 involving 619 patients with chronic spontaneous urticaria, Celltrion submitted a marketing authorization application for the primary indications of asthma, chronic rhinosinusitis, food allergy, and chronic spontaneous urticaria.
The clinical trial was conducted in two dose groups, CT-P39 and XOLAIR, at 300 mg and 150 mg, respectively, with the primary endpoint being the change in Weekly Itch Severity Score (ISS7) at Week 12 from baseline in the 300 mg group.
The results showed that CT-P39 met the pre-defined equivalence criteria, and secondary endpoints of safety and immunogenicity were similar to those of the originator drug.
Before filing in the U.S., Celltrion completed the application in Europe, Canada, and Korea last year. Particularly for the U.S. marketing authorization application, the 'interchangeable' biosimilar is expected to be approved, allowing for rapid market expansion as an alternative prescription to the original product.
XOLAIR, the original drug of CT-P39, is a blockbuster product with global sales of approximately KRW 5 trillion by 2023. The substance patent has already expired, and the formulation patent is scheduled to expire in March 2024 in Europe and November 2025 in the United States.
"CT-P39 has the potential to be a first mover, having demonstrated efficacy and bioequivalence compared to the original drug in global Phase 3 clinical trials, as well as safety compared to competitors," said a Celltrion official. "We will finalize the remaining procedures to speed up the approval process and prepare for market penetration to ensure a smooth supply to the market after approval."
Meanwhile, Celltrion will continue to focus on product development and investment, expanding its biosimilar portfolio to 11 products by 2025, in addition to the six already commercialized.
