Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
Alvotech (NASDAQ: ALVO), in partnership with Kashiv Biosciences and Advanz Pharma, announced positive topline results from their confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab). The study met its primary endpoint, demonstrating therapeutic equivalence and comparable safety to Xolair® in patients with Chronic Spontaneous Urticaria (CSU).
The double-blind study enrolled 600 patients, with 400 receiving the confirmatory dose of 300mg. The primary efficacy measure focused on changes in weekly Itch Severity Score at Week 12. The UK MHRA has already validated the marketing authorization application, with an EMA filing expected by year-end.
Alvotech (NASDAQ: ALVO), in collaborazione con Kashiv Biosciences e Advanz Pharma, ha annunciato risultati positivi preliminari dal loro studio di conferma dell'efficacia per AVT23, un biosimilare proposto di Xolair® (omalizumab). Lo studio ha raggiunto l'endpoint primario, dimostrando equivalenza terapeutica e sicurezza comparabile a Xolair® nei pazienti con Orticaria Cronica Spontanea (CSU).
Lo studio in doppio cieco ha arruolato 600 pazienti, di cui 400 hanno ricevuto la dose confermativa di 300 mg. La misura primaria di efficacia si è concentrata sulle variazioni del punteggio settimanale di gravità del prurito alla settimana 12. L'MHRA del Regno Unito ha già convalidato la domanda di autorizzazione alla commercializzazione, con una presentazione all'EMA prevista entro fine anno.
Alvotech (NASDAQ: ALVO), en colaboración con Kashiv Biosciences y Advanz Pharma, anunció resultados positivos preliminares de su estudio confirmatorio de eficacia para AVT23, un biosimilar propuesto de Xolair® (omalizumab). El estudio cumplió con su objetivo principal, demostrando equivalencia terapéutica y seguridad comparable a Xolair® en pacientes con Urticaria Crónica Espontánea (CSU).
El estudio doble ciego incluyó a 600 pacientes, de los cuales 400 recibieron la dosis confirmatoria de 300 mg. La medida primaria de eficacia se centró en los cambios en la puntuación semanal de severidad del picor en la semana 12. La MHRA del Reino Unido ya ha validado la solicitud de autorización de comercialización, y se espera una presentación a la EMA antes de fin de año.
Alvotech (NASDAQ: ALVO)는 Kashiv Biosciences 및 Advanz Pharma와 협력하여 Xolair®(오말리주맙)의 바이오시밀러 후보인 AVT23에 대한 확인 효능 연구에서 긍정적인 주요 결과를 발표했습니다. 이 연구는 주요 목표를 달성했으며, 만성 자발 두드러기(CSU) 환자에서 Xolair®와 치료적 동등성과 유사한 안전성을 입증했습니다.
이중맹검 연구에는 600명의 환자가 등록되었으며, 그중 400명은 300mg의 확인 용량을 받았습니다. 주요 효능 평가는 12주차의 주간 가려움증 심각도 점수 변화를 중심으로 이루어졌습니다. 영국 MHRA는 이미 판매 승인 신청을 검증했으며, 연말까지 EMA 제출이 예상됩니다.
Alvotech (NASDAQ : ALVO), en partenariat avec Kashiv Biosciences et Advanz Pharma, a annoncé des résultats positifs préliminaires issus de leur étude d'efficacité confirmatoire pour AVT23, un biosimilaire proposé de Xolair® (omalizumab). L'étude a atteint son critère principal, démontrant une équivalence thérapeutique et une sécurité comparable à Xolair® chez des patients atteints d'Urticaire Chronique Spontanée (CSU).
Cette étude en double aveugle a inclus 600 patients, dont 400 ont reçu la dose confirmatoire de 300 mg. Le critère principal d'efficacité portait sur les modifications du score hebdomadaire de sévérité des démangeaisons à la semaine 12. L'MHRA du Royaume-Uni a déjà validé la demande d'autorisation de mise sur le marché, un dépôt auprès de l'EMA étant prévu d'ici la fin de l'année.
Alvotech (NASDAQ: ALVO) hat in Zusammenarbeit mit Kashiv Biosciences und Advanz Pharma positive Zwischenergebnisse aus ihrer bestätigenden Wirksamkeitsstudie für AVT23, einem vorgeschlagenen Biosimilar zu Xolair® (Omalizumab), bekannt gegeben. Die Studie erreichte den primären Endpunkt und zeigte therapeutische Gleichwertigkeit sowie vergleichbare Sicherheit zu Xolair® bei Patienten mit Chronischer Spontaner Urtikaria (CSU).
Die doppelblinde Studie umfasste 600 Patienten, von denen 400 die bestätigende Dosis von 300 mg erhielten. Der primäre Wirksamkeitsparameter konzentrierte sich auf Veränderungen des wöchentlichen Juckreiz-Schweregradscores in Woche 12. Die britische MHRA hat den Zulassungsantrag bereits validiert, eine EMA-Einreichung wird bis Jahresende erwartet.
- Study successfully met primary endpoint demonstrating therapeutic equivalence to Xolair®
- Marketing authorization application already validated by UK MHRA
- EMA filing expected by end of year, indicating regulatory progress
- Large-scale study with 600 patients demonstrates robust clinical evidence
- None.
Insights
Alvotech's biosimilar to Xolair successfully demonstrated equivalence in a pivotal study, moving the product closer to approval and commercialization.
Alvotech's announcement marks a significant milestone in the development of their proposed biosimilar to Xolair® (omalizumab). The confirmatory efficacy study met its primary endpoint, demonstrating therapeutic equivalence between AVT23 and the reference product in patients with Chronic Spontaneous Urticaria (CSU).
The study design was robust and comprehensive, enrolling 600 patients with 400 receiving the confirmatory 300mg dose. Participants received subcutaneous doses every four weeks over a 24-week period, with the primary efficacy measure being the change from baseline in weekly Itch Severity Score at Week 12.
What's particularly noteworthy is that the UK MHRA has already validated and accepted the marketing authorization application for AVT23, with an EMA filing expected before year-end. This regulatory progress, coupled with positive clinical data, positions Alvotech and its partners well in the growing biosimilars market.
The development represents Alvotech's continued execution of its biosimilar strategy, while strengthening Kashiv's portfolio beyond its existing products Releuko® and Fylnetra®. For Advanz Pharma, this advances their strategic focus on specialty, hospital, and rare disease medicines across Europe, Canada, and Australia.
Omalizumab is an anti-IgE monoclonal antibody used in treating allergic asthma and CSU. The original Xolair® is a significant revenue generator for its manufacturer, making this biosimilar potentially valuable for Alvotech and its partners as they work to increase global access while offering a more cost-effective alternative.
REYKJAVIK, ICELAND, PISCATAWAY, NEW JERSEY AND LONDON, UK (June 25, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic.
The randomized, double-blind, multicenter study assessed the efficacy, safety, and immunogenicity of AVT23 compared to Xolair® in patients with Chronic Spontaneous Urticaria (CSU), who remained symptomatic despite treatment with H1 antihistamines. The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks over a 24-week period. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients who received the confirmatory dose of 300 mg. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12 between the treatment groups of ADL-018 and reference product.
“The positive results from this confirmatory patient study represent an important step in the development of the Xolair® biosimilar candidate. We look forward to working with our partners to increase global patient access to this important medicine,” said Joseph McClellan, Chief Scientific Officer of Alvotech.
“This marks a positive advancement for Kashiv’s growing biosimilar pipeline in addition to its current portfolio of Releuko® and Fylnetra®. We look forward to collaborating with regulatory authorities to make this treatment available to patients,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, “We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Alvotech and Advanz Pharma.”
“The successful confirmatory efficacy results for the proposed biosimilar to XOLAIR® mark an important milestone in Advanz Pharma’s ambition to expand patient access to specialty medicines across our core geographies, Europe, Canada, and Australia.” said Nick Warwick, Chief Medical Officer at Advanz Pharma.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has already validated and accepted the marketing authorization application (MAA) for AVT23 earlier this year, and the filing of an MAA with the European Medicines Agency (EMA) is expected before the end of the year.
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 rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy [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.
Alvotech partnered with Kashiv BioSciences for the development of the proposed Xolair® biosimilar, which is referred to as AVT23 by Alvotech and as ADL-018 by Kashiv Biosciences.
Use of trademarks
Xolair® is a registered trademark of Novartis AG.
Sources
[1] MHRA Product Information for Xolair®
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. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. 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 https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability get marketing approval for AVT23 in the UK and other jurisdictions; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. 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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, biosimilars & specialty generics and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, 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.
Advanz Pharma Forward Looking Statements
Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, "expectation", "belief', "estimate", "plan", "target”, “project”, “will”, “may”, “should” or "forecast" and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma’s markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice.
About Kashiv BioSciences:
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
CONTACTS
Alvotech Investor Relations and Global Communications
Benedikt Stefansson, VP
alvotech.ir@alvotech.com
Advanz Pharma Global Corporate Communications
Courtney Baines
courtney.baines@advanzpharma.com
Kashiv Biosciences
Dr. Paras Vasanani
paras.vasanani@kashivbio.com
https://www.kashivbiosciences.com/
FAQ
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