UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab)
Alvotech (NASDAQ: ALVO), along with Kashiv Biosciences and Advanz Pharma, announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted their marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab).
The biosimilar is intended for treating severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. The original drug, Xolair, generated global sales of approximately $4.4 billion in 2024.
This development follows strategic partnerships formed in 2023, including a commercialization agreement between Alvotech and Advanz Pharma for AVT23 in February, an expanded partnership in May covering five additional biosimilar candidates, and a licensing agreement between Alvotech and Kashiv in October.
Alvotech (NASDAQ: ALVO), insieme a Kashiv Biosciences e Advanz Pharma, ha annunciato che l'Agenzia Regolatoria dei Farmaci e dei Prodotti Sanitari del Regno Unito (MHRA) ha accettato la loro domanda di commercializzazione per AVT23, un biosimilare proposto di Xolair® (omalizumab).
Il biosimilare è destinato al trattamento di asma allergico persistente grave e rhinosinusite cronica con polipi nasali. Il farmaco originale, Xolair, ha generato vendite globali di circa 4,4 miliardi di dollari nel 2024.
Questo sviluppo segue le partnership strategiche formate nel 2023, inclusi un accordo di commercializzazione tra Alvotech e Advanz Pharma per AVT23 a febbraio, un'alleanza ampliata a maggio che copre cinque ulteriori candidati biosimilari, e un accordo di licenza tra Alvotech e Kashiv in ottobre.
Alvotech (NASDAQ: ALVO), junto con Kashiv Biosciences y Advanz Pharma, anunció que la Agencia Reguladora de Medicamentos y Productos de Salud del Reino Unido (MHRA) ha aceptado su solicitud de comercialización para AVT23, un biosimilar propuesto de Xolair® (omalizumab).
El biosimilar está destinado a tratar asma alérgico persistente severo y rinosinusitis crónica con pólipos nasales. El medicamento original, Xolair, generó ventas globales de aproximadamente 4.4 mil millones de dólares en 2024.
Este desarrollo sigue a las asociaciones estratégicas formadas en 2023, incluyendo un acuerdo de comercialización entre Alvotech y Advanz Pharma para AVT23 en febrero, una asociación ampliada en mayo que cubre cinco candidatos biosimilares adicionales, y un acuerdo de licencia entre Alvotech y Kashiv en octubre.
Alvotech (NASDAQ: ALVO)는 Kashiv Biosciences 및 Advanz Pharma와 함께 영국 의약품 및 건강 관리 제품 규제 기관(MHRA)이 AVT23의 마케팅 신청을 수락했다고 발표했습니다. 이는 Xolair® (omalizumab)의 제안된 바이오시밀러입니다.
이 바이오시밀러는 심각한 지속성 알레르기 천식 및 만성 비부비동염을 치료하는 데 사용될 예정입니다. 원래 약물인 Xolair는 2024년에 약 44억 달러의 글로벌 매출을 기록했습니다.
이 개발은 2023년에 체결된 전략적 파트너십에 이어 진행되며, 2월에 Alvotech와 Advanz Pharma 간의 AVT23 상용화 계약, 5월에 다섯 개의 추가 바이오시밀러 후보를 포함하는 파트너십 확대, 10월에 Alvotech와 Kashiv 간의 라이센스 계약이 포함됩니다.
Alvotech (NASDAQ: ALVO), en collaboration avec Kashiv Biosciences et Advanz Pharma, a annoncé que l'Agence britannique des médicaments et des produits de santé (MHRA) a accepté leur demande de commercialisation pour AVT23, un biosimilaire proposé de Xolair® (omalizumab).
Le biosimilaire est destiné à traiter l'asthme allergique persistant sévère et la rhinosinusite chronique avec polypes nasaux. Le médicament original, Xolair, a généré des ventes mondiales d'environ 4,4 milliards de dollars en 2024.
Ce développement fait suite à des partenariats stratégiques formés en 2023, y compris un accord de commercialisation entre Alvotech et Advanz Pharma pour AVT23 en février, un partenariat élargi en mai couvrant cinq candidats biosimilaires supplémentaires, et un accord de licence entre Alvotech et Kashiv en octobre.
Alvotech (NASDAQ: ALVO) hat zusammen mit Kashiv Biosciences und Advanz Pharma bekannt gegeben, dass die britische Behörde für Arzneimittel und Gesundheitsprodukte (MHRA) ihren Antrag auf Marktzulassung für AVT23, ein vorgeschlagenes Biosimilar zu Xolair® (omalizumab), angenommen hat.
Das Biosimilar soll zur Behandlung von schwerem persistierendem allergischem Asthma und chronischer Rhinosinusitis mit Nasenpolypen eingesetzt werden. Das Originalmedikament, Xolair, erzielte im Jahr 2024 einen globalen Umsatz von etwa 4,4 Milliarden US-Dollar.
Diese Entwicklung folgt strategischen Partnerschaften, die 2023 gebildet wurden, einschließlich eines Kommerzialisierungsvertrags zwischen Alvotech und Advanz Pharma für AVT23 im Februar, einer erweiterten Partnerschaft im Mai, die fünf weitere Biosimilar-Kandidaten umfasst, und einem Lizenzvertrag zwischen Alvotech und Kashiv im Oktober.
- Acceptance of marketing authorization application by UK MHRA for AVT23 biosimilar
- Target market size of $4.4 billion based on Xolair's 2024 global sales
- Strategic partnerships secured with Advanz Pharma and Kashiv Biosciences for development and commercialization
- None.
Insights
The MHRA's acceptance of the marketing authorization application for AVT23 represents a significant regulatory milestone in Alvotech's biosimilar development program. This acceptance indicates the application package met basic requirements for review, but investors should understand this is an intermediate step in a multi-phase approval process, not a final authorization.
Targeting Xolair (omalizumab) is strategically sound, as this $4.4 billion biologic addresses two substantial indications: severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. The UK application potentially positions Alvotech to capture market share in a region with established biosimilar adoption patterns.
The timing aligns with Alvotech's broader partnership strategy, connecting development expertise (Alvotech), specialized formulation capabilities (Kashiv), and established market distribution channels (Advanz). This three-way collaboration reflects the complex expertise required in successful biosimilar commercialization.
Looking at regulatory implications, this acceptance suggests Alvotech has likely compiled robust comparative analytical data demonstrating similarity to the reference product. The next critical phase will be the MHRA's comprehensive assessment of clinical equivalence data, manufacturing consistency, and immunogenicity profiles before any potential approval.
The MHRA application acceptance for AVT23 strengthens Alvotech's position in the competitive biosimilar market. With Xolair generating
This development should be viewed within Alvotech's broader partnership strategy. The 2023 agreements with Advanz Pharma (including five additional biosimilar candidates) and the licensing arrangement with Kashiv suggest a comprehensive commercialization roadmap. The company is effectively distributing development costs while establishing multiple revenue channels.
For investors, three critical value considerations emerge: First, the UK represents an appealing initial market with its established biosimilar adoption framework. Second, the commercial partnerships reduce Alvotech's go-to-market risk. Third, this acceptance reinforces the company's technical capabilities in developing complex biologics.
While this milestone suggests positive pipeline progression, revenue impact remains distant as the regulatory review, potential approval, and market launch would occur sequentially. Investors should monitor for MHRA's decision timeline and any parallel regulatory submissions in other jurisdictions, especially given Alvotech's global focus. The partnership structure also raises questions about revenue-sharing arrangements that will determine Alvotech's ultimate financial benefit.
REYKJAVIK, Iceland, PISCATAWAY, N.J. and LONDON, March 26, 2025 (GLOBE NEWSWIRE) -- 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, a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were about USD
“This represents an important step in the development of our proposed biosimilar to Xolair, with the key goal to increase patient access to an important biologic,” said Joseph McClellan, Chief Scientific Officer of Alvotech.
“At Kashiv, we are committed to developing high-quality, cost-effective therapies. The successful acceptance by MHRA of the marketing authorization for AVT23 reflects our dedication to innovation and improving access to vital biosimilars on a global scale,” said Chirag and Chintu Patel, Executive Chairman and Co-Founders of Kashiv Biosciences.
Dr Nick Warwick, Chief Medical Officer of Advanz Pharma, stated, "This achievement marks a significant step in expanding treatment options for patients and reinforces Advanz Pharma's dedication to enhancing access to specialty, hospital, and rare disease medications.”
Alvotech and Advanz Pharma announced in February 2023 that the companies had entered into a commercialization agreement for AVT23. In May 2023, the partners announced an expansion of the strategic partnership, to include five additional biosimilar candidates under development by Alvotech. Alvotech and Kashiv announced in October 2023 that the companies had entered into a licensing agreement for AVT23.
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 and chronic rhinosinusitis with nasal polyps (CRSwNP) [2]. 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] Financial Reports from Roche Group and Novartis
[2] MHRA Product Information for Xolair®
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. 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 to 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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ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com
FAQ
What is the market size for Xolair that ALVO's biosimilar AVT23 is targeting?
What medical conditions will ALVO's AVT23 biosimilar treat?
What regulatory milestone did ALVO achieve for its Xolair biosimilar in the UK?
What strategic partnerships has ALVO formed for AVT23 development and commercialization?
