Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
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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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. 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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.
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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
[email protected]
Advanz Pharma Global Corporate Communications
Courtney Baines
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Kashiv Biosciences
Dr. Paras Vasanani
[email protected]
https://www.kashivbiosciences.com/
