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 619 CSU pts for 12wks., followed by re-randomization of comparator arm to Omlyclo or Xolair. From Wk. 24, pts were monitored without dosing until Wk. 40
- Study demonstrated interchangeability with reference product, showing comparable efficacy & safety during both treatment & off-dose period
Ref: Celltrion | Image: Celltrion
Related News:- Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
