Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Shots: The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU) Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in…

ByDipanshu DixitMarch 10, 2025

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 &…

ByDipanshu DixitDecember 9, 2024

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP) The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK…

ByDipanshu DixitMay 23, 2024

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

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

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

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