LONDON and REYKJAVIK, Iceland, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT2 ...

Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) who were symptomatic despite H1 antihistamine treatment [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a confirmatory dose of 300 mg over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of the study results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted the milestone in expanding patient access to specialty medicines in key markets [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing to the European Medicines Agency (EMA) expected by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with a pipeline that includes nine disclosed biosimilar candidates targeting various therapeutic areas [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a robust infrastructure for R&D, clinical, manufacturing, and regulatory capabilities [16] - Advanz Pharma aims to improve patient lives through specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [14]

Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a 300 mg dose over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of these results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted that the results mark a significant milestone in expanding access to specialty medicines [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing expected with the European Medicines Agency (EMA) by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma and other conditions [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with two biosimilars already approved and a pipeline of nine candidates targeting various diseases [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a strong focus on biosimilars and advanced clinical-stage assets [16] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a global presence in over 90 countries [14]

Core Insights - Dupixent demonstrated superior efficacy compared to Xolair in treating chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma, achieving significant improvements in various endpoints as early as 4 weeks [1][2][3] Group 1: Trial Overview - The EVEREST Phase 4 trial involved 360 adults with severe, uncontrolled CRSwNP and coexisting asthma, comparing Dupixent (300 mg every two weeks) to Xolair (dosing based on weight and IgE levels) [2][5] - Both treatments were administered alongside mometasone furoate nasal spray [2][5] Group 2: Efficacy Results - Dupixent achieved a 1.60-point superior reduction in nasal polyp size (p<0.0001) and an 8.0-point superior improvement in smell identification (p<0.0001) [4] - Other notable results included a 0.58-point reduction in nasal congestion (p<0.0001), a 1.74-point reduction in symptom severity (p<0.0001), and a 12.7-point improvement in health-related quality of life (p<0.0001) [4] Group 3: Safety Profile - The safety profile of Dupixent was consistent with its known profile, with adverse event rates of 64% for Dupixent and 67% for Xolair [3] - Serious adverse events were reported in 2% of Dupixent patients compared to 4% for Xolair, and discontinuation due to adverse events occurred in 3% of Dupixent patients versus 1% for Xolair [3] Group 4: Mechanism of Action - Dupixent targets IL-4 and IL-13 pathways, which are key drivers of type 2 inflammation, providing significant clinical benefits in respiratory diseases [1][7] Group 5: Market Context - Dupixent has received regulatory approvals in over 60 countries for various indications, with more than 1,000,000 patients currently treated globally [8][9]