Celltrion Reports Preliminary Results from the P-III Clinical Trial of CT-P39 (biosimilar, omalizumab) for Allergic Asthma and Chronic Urticaria
Shots:
- The company highlighted the preliminary data from a P-III clinical trial evaluating omalizumab biosimilar CT-P39 in patients with chronic spontaneous urticaria
- The results showed that CT-P39 met the pre-defined equivalence criteria and demonstrated similar results to Xolair in terms of efficacy, safety, immunogenicity, and PK. Xolair’s substance patent has already expired and the formulation patent is set to expire in March 2024 in the EU & Nov 2025 in the US
- Xolair (developed by Genentech & Novartis) is used to treat allergic asthma, chronic urticaria & nasal polyps. The company plans to complete the remaining P-III studies of CT-P39 and file for product license in Korea and other countries in 2023
Ref: Center For Biosimilars | Image: Celltrion
Related News:- Celltrion Reports Results of CT-P39 (biosimilar, omalizumab) in P-I Study for Asthma and Chronic Idiopathic Urticaria
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