Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots: Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25 The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…

ByDipanshu DixitJune 27, 2025

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Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Shots: The P-II trial assessed barzolvolimab (Q4W: 75 or 150mg; Q8W: 300mg) vs PBO for 16wks. in 208 CSU pts unresponsive to antihistamines, followed by 36wks. of active treatment, where 75mg & PBO pts were re-randomized to 150 or 300mg; pts were then followed for 24wks. Enrolment to P-III (EMBARQ-CSU1 & EMBARQ-CSU2) trials is ongoing …

ByRidhi RastogiJune 13, 2025

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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

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

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

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