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…

ByDipanshu DixitMay 23, 2024

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Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Shots: Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU The submission was supported by the data, showing comparable efficacy & safety, from P-III study…

ByDipanshu DixitMarch 10, 2024

Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

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