European Marketing Application for AVT23, a Proposed Biosimilar to Xolair® (omalizumab), Accepted by the European Medicines Agency
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced the EMA accepted a Marketing Authorization Application (MAA) for AVT23, a proposed biosimilar to Xolair (omalizumab), on Oct 6, 2025, the PR states.
The PR notes Alvotech developed AVT23 with Kashiv BioSciences and that Advanz Pharma holds licensed commercial rights in the EEA, UK, Switzerland, Canada, Australia, and New Zealand. The PR also states the UK MHRA accepted an MAA earlier in 2025. The companies frame the acceptance as a regulatory milestone toward broader patient access to omalizumab biosimilar therapy in respiratory and allergic indications.
Alvotech (NASDAQ: ALVO) e Advanz Pharma hanno annunciato che l'EMA ha accettato una Domanda di Autorizzazione all’Immissione in commercio (MAA) per AVT23, un presunto biosimilare di Xolair (omalizumab), in data 6 ottobre 2025, secondo il comunicato stampa.
Il comunicato sottolinea che Alvotech ha sviluppato AVT23 insieme a Kashiv BioSciences e che Advanz Pharma detiene i diritti commerciali concessi in licenza nell'UE, Regno Unito, Svizzera, Canada, Australia e Nuova Zelanda. Il comunicato afferma anche che la MHRA del Regno Unito ha accettato una MAA all'inizio del 2025. Le aziende inquadrano l'accettazione come una tappa normativa verso un accesso più ampio dei pazienti alla terapia biosimilare di omalizumab per indicazioni respiratorie e allergiche.
Alvotech (NASDAQ: ALVO) y Advanz Pharma anunciaron que la EMA aceptó una Solicitud de Autorización de Comercialización (MAA) para AVT23, un biosimilar propuesto de Xolair (omalizumab), el 6 de octubre de 2025, según el comunicado.
El comunicado señala que Alvotech desarrolló AVT23 junto a Kashiv BioSciences y que Advanz Pharma posee derechos comerciales con licencia en la EEA, Reino Unido, Suiza, Canadá, Australia y Nueva Zelanda. El comunicado también afirma que la MHRA del Reino Unido aceptó una MAA a principios de 2025. Las empresas enmarcan la aceptación como un hito regulatorio hacia un mayor acceso de los pacientes a la terapia biosimilar de omalizumab en indicaciones respiratorias y alérgicas.
알보텍(NASDAQ: ALVO)와 Advanz Pharma은 AVT23에 대한 마케팅 승인 신청(MAA)이 EMA에 의해 수용되었다, 이는 Xolair(얼로뮤주맙)의 바이오시밀러 후보이며, 2025년 10월 6일에 발표된 보도자료에 따른다.
보도자료는 알보텍이 Kashiv BioSciences와 함께 AVT23을 개발했고 Advanz Pharma가 EU, 영국, 스위스, 캐나다, 호주, 뉴질랜드에서 라이선스가 부여된 상업적 권리를 보유하고 있다고 언급한다. 보도자료는 또한 영국 MHRA가 2025년 초에 MAA를 수용했다. 기업들은 이 수용을 호흡기 및 알레르기 적응증에서 옴라지주맙 바이오시밀러 치료에 대한 더 넓은 환자 접근의 규제적 이정표로 보고 있다.
Alvotech (NASDAQ: ALVO) et Advanz Pharma ont annoncé que l'EMA a accepté une Demande d'Autorisation de Mise sur le Marché (MAA) pour AVT23, un biosimilaire proposé de Xolair (omalizumab), le 6 octobre 2025, selon le communiqué.
Le communiqué indique qu'Alvotech a développé AVT23 avec Kashiv BioSciences et que Advanz Pharma détient les droits commerciaux sous licence dans l'EEE, Royaume-Uni, Suisse, Canada, Australie et Nouvelle-Zélande. Le communiqué indique également que la MHRA du Royaume-Uni a accepté une MAA plus tôt en 2025. Les entreprises présentent cette acceptation comme une étape réglementaire vers un accès patient élargi à la thérapie biosimilaire de l’omalizumab dans les indications respiratoires et allergiques.
Alvotech (NASDAQ: ALVO) und Advanz Pharma gaben bekannt, dass die EMA eine Marketingzulassungsanfrage (MAA) für AVT23 akzeptiert hat, einen vorgeschlagenen Biosimilar zu Xolair (Omalizumab), am 6. Oktober 2025, so die Pressemitteilung.
Die Pressemitteilung bemerkt, dass Alvotech AVT23 zusammen mit Kashiv BioSciences entwickelt hat und dass Advanz Pharma in der EEA, UK, Schweiz, Kanada, Australien und Neuseeland lizenzierte kommerzielle Rechte hält. Die Pressemitteilung besagt auch, dass die UK MHRA zu Beginn von 2025 eine MAA akzeptierte. Die Unternehmen sehen die Annahme als regulatorische Meilenstein auf dem Weg zu einem breiteren Patientenzugang zur omalizumab-biosimilars Therapie in Atemwegs- und allergischen Indikationen.
ألفوتيك (بورصة ناسداك: ALVO) و Advanz Pharma أعلنوا أن EMA وافقت على طلب ترخيص تسويق (MAA) لـ AVT23، وهو biosimilar مقترح لـ Xolair (omalizumab)، في 6 أكتوبر 2025، وفقاً لبيان صحفي.
يشير البيان الصحفي إلى أن ألفوتيك طورت AVT23 مع Kashiv BioSciences وأن Advanz Pharma تحتفظ بحقوق تجارية مرخصة في المنطقة الاقتصادية الأوروبية، المملكة المتحدة، سويسرا، كندا، أستراليا ونيوزيلندا. كما تشير البيانات إلى أن MHRA البريطانية قبلت MAA في وقت مبكر من 2025. تعتبر الشركات القبول خطوة تنظيمية نحو وصول أوسع للمرضى إلى علاج omalizumab-biosimilar في المؤشرات التنفسية والحساسية.
Alvotech (NASDAQ: ALVO) 与 Advanz Pharma 宣布 EMA 已接受 AVT23 的上市许可申请 (MAA)，这是一种拟议的 Xolair（omalizumab）生物类似药，日期为 2025年10月6日，新闻稿所述。
新闻稿指出，Alvotech 与 Kashiv BioSciences 共同开发了 AVT23，Advanz Pharma 在 欧洲经济区、英国、瑞士、加拿大、澳大利亚和新西兰 拥有许可商业权。新闻稿还称 英国 MHRA 在2025年初接受了 MAA。两家公司将这一接受描述为朝向让患者在呼吸和过敏适应症中更广泛使用 omalizumab 生物类似药的监管里程碑。
- EMA accepted MAA for AVT23 on Oct 6, 2025
- MHRA accepted MAA for AVT23 earlier in 2025
- Advanz licensed commercial rights across EEA, UK, Switzerland, Canada, Australia, New Zealand
- EMA acceptance is review start; final approval not granted
- No commercial terms or launch timeline disclosed in the PR
Insights
EMA acceptance of the AVT23 marketing application advances regulatory review and preserves commercial pathways in major territories.
The article states the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair® (omalizumab), and notes prior acceptance by the MHRA. This means regulators deemed the dossier complete enough to start scientific assessment, moving the program from pre‑review to formal evaluation.
Why it matters: acceptance starts the clock on EMA review and signals progress toward potential market entry across the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand per the disclosed license. Acceptance is a material regulatory milestone because a favorable EMA outcome would enable commercialization in a large addressable market for severe allergic asthma and related indications; conversely, acceptance is not an approval and does not guarantee a positive decision.
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 AVT23, a proposed biosimilar to Xolair® (omalizumab).
Nick Warwick, Chief Medical Officer of Advanz Pharma said, "The EMA’s acceptance of the marketing application for AVT23 marks an important milestone in our mission to expand access to high-quality, affordable biologic medicines for patients across Europe. We look forward to working with Alvotech to bring this important therapy closer to the patients who need it."
"Bringing us a step closer to offering this important therapy in respiratory disease more broadly, is excellent news for our partnership with Advanz Pharma, patients and caregivers. Alvotech is focused on leveraging its end-to-end biosimilars platform in support of broader access to affordable biologic medicines," said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.
Alvotech developed AVT23 in collaboration with Kashiv BioSciences LLC, and Advanz Pharma has licensed commercial rights in the European Economic Area (European Union, Norway, Iceland and Lichtenstein), UK, Switzerland, Canada, Australia and New Zealand. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) accepted a Marketing Authorization Application for AVT23 earlier this year.
Omalizumab is a prescription biologic medicine used to improve the control of severe persistent asthma caused by an allergy. It is also used to treat long-term itchy rash (chronic spontaneous urticaria) and inflamed lining of the nose and sinuses with swellings in the nose (severe chronic rhinosinusitis with nasal polyps).
About AVT23
AVT23 is a proposed biosimilar to Xolair® (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair®, which contains omalizumab, is indicated for severe persistent allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps (CRSwNP) [1]. AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
Sources
[1] Xolair EMA product information
Use of trademarks
Xolair® is a registered trademark of Novartis AG.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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About Advanz Pharma
Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.
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CONTACTS
ALVOTECH
Benedikt Stefansson, VP Investor Relations and Global Communications
alvotech.ir@alvotech.com
ADVANZ PHARMA
Courtney Baines
Tel: +44 7776 516979
courtney.baines@advanzpharma.com
FAQ
What did Alvotech (ALVO) announce about AVT23 on Oct 6, 2025?
Has the UK regulator reviewed AVT23 for Alvotech (ALVO)?
Which territories hold commercial rights for AVT23 according to the PR?
Does EMA acceptance mean AVT23 is approved for sale in Europe?
Who developed AVT23 with Alvotech (ALVO)?
What indications does the PR link AVT23 (omalizumab biosimilar) to?
