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Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair)

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Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair)

Shots:

  • The Health Canada has granted approval to Celltrion’s Omlyclo, a biosimilar version of Xolair (omalizumab)
  • The approval was based on clinical outcomes incl. P-III trial assessing the safety, efficacy & PK/PD of Omlyclo vs Xolair in patients with chronic idiopathic urticaria (CIU) for over 40wks., depicting therapeutic equivalence b/w the drugs
  • Omlyclo (75mg/0.5mL & 150mg/1.0mL, SC) is approved to treat patients (≥12yrs.) with chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU), patients (≥6yrs.) with allergic asthma & adults having chronic rhinosinusitis with nasal polyps (CRSwNP)

Ref: Businesswire | Image: Celltrion

Related News:- Celltrion’s SteQeyma (Biosimilar, Stelara) Receives the EC’s Approval to Treat Various Chronic Inflammatory Diseases

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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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