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

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AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

Shots:The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countriesOpinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…

ByRidhi RastogiSeptember 24, 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

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

Shots:The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNPAlvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech &…

ByRidhi RastogiMarch 26, 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

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GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025

Shots:The P-III (ANCHOR-1: N=271, ANCHOR-2: N=257) trial assessed depemokimab + SoC vs PBO + SoC in CRSwNP pts that showed early benefits lasting over 52wks. ANCHOR data with SWIFT-1 & 2 trial data will support global filings for asthma with type 2 inflammation & CRSwNP Pooled analysis of 2EPs showed 0.7-point NPS decrease (-0.9 to…

ByRidhi RastogiMarch 3, 2025

NEWS

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots:The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

BySenior EditorJanuary 28, 2025

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

AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

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

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

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

GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

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