ACM Research Reports First Quarter 2025 Results

Rhea-AI Summary

Alvotech (NASDAQ: ALVO), Kashiv Biosciences, and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab). The biosimilar targets treatments for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps.

Xolair recorded global sales of $4.4 billion in 2024. The development builds on previous partnerships, including a February 2023 commercialization agreement between Alvotech and Advanz Pharma for AVT23, which was expanded in May 2023 to include five additional biosimilar candidates. Additionally, Alvotech and Kashiv established a licensing agreement for AVT23 in October 2023.

Positive

• MHRA acceptance of marketing application for AVT23 biosimilar represents regulatory progress
• Target reference drug Xolair has significant market size with $4.4 billion in global sales (2024)
• Strategic partnerships and licensing agreements in place for commercialization

Negative

• Product still requires full regulatory approval
• Will face competition from established Xolair brand and potentially other biosimilars

Insights

Pharmaceutical Industry Analyst

MHRA acceptance of Alvotech's Xolair biosimilar application marks regulatory progress toward commercializing a potential competitor in a $4.4B market.

The acceptance of a marketing application by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for AVT23 represents a significant regulatory milestone for Alvotech and its partners. AVT23 is positioned as a biosimilar to Xolair (omalizumab), which generated approximately $4.4 billion in global sales in 2024.

This regulatory acceptance is an important procedural step that indicates the submission contains the necessary elements for formal review. However, it's worth distinguishing that acceptance for review is distinct from approval – this marks the beginning of the substantive evaluation process rather than its conclusion.

The collaboration structure here is notable, involving three specialized companies: Alvotech focusing on biosimilar development, Kashiv Biosciences contributing to development, and Advanz Pharma handling commercialization with expertise in specialty and rare disease medications. This tripartite structure leverages complementary capabilities across the development-to-market continuum.

The commercial potential derives from Xolair's established position in treating severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Biosimilars typically enter markets at lower price points than reference products, potentially expanding patient access while capturing market share.

This application specifically targets the UK market, and the press release doesn't mention regulatory submissions in other territories. Given that $4.4 billion represents global sales, the UK-specific opportunity represents just a fraction of that figure.

The timing of this development builds upon previously announced partnerships: the commercialization agreement between Alvotech and Advanz from February 2023, their expanded partnership from May 2023 covering five additional biosimilar candidates, and the October 2023 licensing agreement between Alvotech and Kashiv specifically for AVT23.

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 $4.4 billion [1]. 

“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 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. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.

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?

Xolair recorded global sales of $4.4 billion in 2024, representing the market potential for AVT23.

What conditions will Alvotech's AVT23 biosimilar treat?

AVT23 is designed to treat severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps.

What regulatory milestone did ALVO achieve for its Xolair biosimilar?

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) accepted the marketing application for AVT23, Alvotech's proposed biosimilar to Xolair.

Who are Alvotech's partners for the AVT23 biosimilar development and commercialization?

Alvotech has partnerships with Kashiv Biosciences for licensing and Advanz Pharma for commercialization of AVT23.

When did Alvotech establish its partnership with Advanz Pharma for AVT23?

Alvotech and Advanz Pharma established their commercialization agreement for AVT23 in February 2023, later expanding it in May 2023 to include five additional biosimilar candidates.