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Celltrion Reports Submission of a Marketing Application to Health Canada for CT-P39 for all Originator Indications

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Celltrion Reports Submission of a Marketing Application to Health Canada for CT-P39 for all Originator Indications

Shots: 

  • The application was submitted based on the results from the P-III clinical trial evaluating the safety & efficacy of CT-P39 vs Xolair in patients (n=619) with chronic spontaneous urticaria (CSU) across 6 EU countries  
  • Results from the study supporting filling with Health Canada to gain approval for all approved indications of Xolair (Incl. allergic asthma, chronic rhinosinusitis & chronic urticaria)  
  • The originator of CT-P39, Xolair is an antibody developed jointly by Genentech and Novartis. XOLAIR's material patent has expired, Whereas, formulation patent expires in Mar 2024 in EU & Nov 2025 in the US  

Ref: The Bio | Image: Celltrion

Related News:- Celltrion Reports Preliminary Results from the P-III Clinical Trial of CT-P39 (biosimilar, omalizumab) for Allergic Asthma and Chronic Urticaria

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Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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