Skip to content Skip to footer
Subscribe Now
Celltrion
News

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 &…
December 9, 2024

Read more

Celltrion
News

Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications 

Shots: EMA received CHMP’s recommendation to grant marketing authorization for full-label application of Celltrion’s CT-P39, developed as a biosimilar to Xolair (omalizumab). The company expects to receive EC’s approval by early May 2024 Xolair is a monoclonal antibody approved for the treatment of various indications incl. Allergic Asthma, Nasal Polyps, and Chronic Hives. Recently, Xolair…
May 23, 2024

Read more