Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots:The EMA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab), following the MHRA’s MAA acceptance earlier this yearAVT23 was jointly developed by Alvotech & Kashiv BioSciences, with Advanz Pharma obtaining commercial rights to AVT23 in the EEA, UK, Switzerland, Canada, Australia and New ZealandOmalizumab is a humanized mAb that…

ByRidhi RastogiOctober 6, 2025

NEWS

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Shots:The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in ChinaApproval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved…

ByRidhi RastogiOctober 1, 2025

NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots:The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciencesAdditionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approvalXolair is…

ByRidhi RastogiSeptember 29, 2025

NEWS

Kashiv BioSciences Collaborates with CRISTÁLIA to Commercialize ADL-018 (Biosimilar, Xolair) in Latin America

Shots:Kashiv BioSciences has entered into a licensing & supply agreement with CRISTÁLIA for the commercialization of ADL-018, a biosimilar version of Xolair (omalizumab) in Latin AmericaAs per the deal, CRISTÁLIA will handle licensing, distribution, & commercialization of ADL-018 in the LATAM region, while Kashiv BioSciences will be responsible for the development within the agreed…

ByRidhi RastogiSeptember 12, 2025

NEWS

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 Q4’25The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…

ByDipanshu DixitJune 27, 2025

NEWS

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

NEWS

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

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Kashiv BioSciences Collaborates with CRISTÁLIA to Commercialize ADL-018 (Biosimilar, Xolair) in Latin America

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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