Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications
Shots:
- EMA received CHMP’s recommendation to grant marketing authorization for full-label application of Celltrion’s CT-P39, developed as a biosimilar to Xolair (omalizumab). The company expects to receive EC’s approval by early May 2024
- Xolair is a monoclonal antibody approved for the treatment of various indications incl. Allergic Asthma, Nasal Polyps, and Chronic Hives. Recently, Xolair also received approval for the treatment of food allergy indications
- Moreover, in Mar 2024, the company also completed its application to the US FDA to receive approval for CT-P39. Celltrion aims to expand its biosimilar portfolio to 11 products by 2025
Ref: Celltrion | Image: Celltrion
Related News:- Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
