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:  Celltrion| Image: Celltrion | Press Release

Related News:- Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra) 

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