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

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


  • 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: Celltrion | Image: Celltrion

Related News:- Celltrion’s Zymfentra (Infliximab-Dyyb) Receives the US FDA’s Approval for the Treatment of Inflammatory Bowel Disease

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Disha Nankani

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.

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