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 aimed at investigating the safety, efficacy & PK of CT-P39 vs the reference product to treat chronic spontaneous urticaria (CSU) patients for up to wk. 40. The results from wk. 12 were highlighted at the ACAAI conference, 2024 

• Additionally, Xolair’s US formulation patent will expire in Nov 2025 while its compound patent is already expired 

Ref: PR Newswire | Image: Celltrion | Press Release

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