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: Businesswire | Image: Celltrion| Press Release

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