European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
Alvotech (NASDAQ: ALVO) announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). This marks a significant step towards making AVT03 available in Europe.
The company recently reported positive topline results from confirmatory studies for AVT03, demonstrating clinical similarity to Prolia in efficacy, safety, immunogenicity, and pharmacokinetics. Alvotech develops and manufactures AVT03, with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA as commercial partners in Europe.
The European denosumab market is valued at approximately US$1 billion. Biosimilar competition could expand patient access at lower costs, addressing the significant burden of osteoporosis in Europe, where an estimated 32 million individuals are affected, but 70% of eligible women do not receive treatment.
Alvotech (NASDAQ: ALVO) ha annunciato che l'Agenzia Europea per i Medicinali (EMA) ha accettato una domanda di autorizzazione all'immissione in commercio per AVT03, un biosimilare proposto per Prolia® e Xgeva® (denosumab). Questo rappresenta un passo significativo verso la disponibilità di AVT03 in Europa.
Recentemente, l'azienda ha riportato risultati positivi preliminari da studi di conferma per AVT03, dimostrando una somiglianza clinica con Prolia in termini di efficacia, sicurezza, immunogenicità e farmacocinetica. Alvotech sviluppa e produce AVT03, con STADA Arzneimittel AG e Dr. Reddy's Laboratories SA come partner commerciali in Europa.
Il mercato europeo del denosumab è valutato circa 1 miliardo di dollari USA. La concorrenza dei biosimilari potrebbe aumentare l'accesso per i pazienti a costi inferiori, affrontando il significativo onere dell'osteoporosi in Europa, dove circa 32 milioni di individui sono colpiti, ma il 70% delle donne idonee non riceve trattamento.
Alvotech (NASDAQ: ALVO) anunció que la Agencia Europea de Medicamentos (EMA) ha aceptado una Solicitud de Autorización de Comercialización para AVT03, un biosimilar propuesto para Prolia® y Xgeva® (denosumab). Este es un paso significativo hacia la disponibilidad de AVT03 en Europa.
Recientemente, la empresa informó sobre resultados preliminares positivos de estudios confirmatorios para AVT03, demostrando similitud clínica con Prolia en eficacia, seguridad, inmunogenicidad y farmacocinética. Alvotech desarrolla y produce AVT03, teniendo a STADA Arzneimittel AG y Dr. Reddy's Laboratories SA como socios comerciales en Europa.
El mercado europeo de denosumab se valora en aproximadamente 1 mil millones de dólares estadounidenses. La competencia de biosimilares podría ampliar el acceso de los pacientes a costos más bajos, abordando la significativa carga de la osteoporosis en Europa, donde se estima que 32 millones de personas están afectadas, pero el 70% de las mujeres elegibles no recibe tratamiento.
Alvotech (NASDAQ: ALVO)는 유럽 의약품 청(EMA)이 Prolia®와 Xgeva®(denosumab)의 제안된 바이오시밀러인 AVT03에 대한 마케팅 허가 신청을 수락했다고 발표했습니다. 이는 AVT03의 유럽 출시를 향한 중요한 진전을 나타냅니다.
회사는 최근 AVT03의 확인 연구에서 긍정적인 주요 결과를 보고했으며, Prolia와 의학적으로 유사함을 입증했습니다. 안전성, 면역원성 및 약물동태 측면에서도 비슷합니다. Alvotech는 AVT03을 개발 및 제조하고 있으며, 유럽에서 상업적 파트너로 STADA Arzneimittel AG와 Dr. Reddy's Laboratories SA가 있습니다.
유럽의 denosumab 시장은 약 10억 달러 미국으로 평가됩니다. 바이오시밀러의 경쟁은 더 낮은 비용으로 환자의 접근을 확대할 수 있으며, 유럽에서 약 3,200만 명이 영향을 받는 골다공증의 상당한 부담을 해결할 수 있습니다. 그러나 적격 여성의 70%는 치료를 받지 않고 있습니다.
Alvotech (NASDAQ: ALVO) a annoncé que l'Agence européenne des médicaments (EMA) a accepté une demande d'autorisation de mise sur le marché pour AVT03, un biosimilaire proposé aux produits Prolia® et Xgeva® (dénosumab). Cela marque une étape importante vers la disponibilité d'AVT03 en Europe.
L'entreprise a récemment rapporté des résultats préliminaires positifs d'études de confirmation pour AVT03, démontrant une similarité clinique avec Prolia en termes d'efficacité, de sécurité, d'immunogénicité et de pharmacocinétique. Alvotech développe et fabrique AVT03, avec STADA Arzneimittel AG et Dr. Reddy's Laboratories SA comme partenaires commerciaux en Europe.
Le marché européen du dénosumab est évalué à environ 1 milliard de dollars américains. La concurrence des biosimilaires pourrait élargir l'accès des patients à des coûts inférieurs, abordant le fardeau significatif de l'ostéoporose en Europe, où environ 32 millions de personnes sont touchées, mais 70 % des femmes éligibles ne reçoivent pas de traitement.
Alvotech (NASDAQ: ALVO) hat bekanntgegeben, dass die Europäische Arzneimittel-Agentur (EMA) einen Antrag auf Marktzulassung für AVT03, ein vorgeschlagenes Biosimilar zu Prolia® und Xgeva® (Denosumab), angenommen hat. Dies ist ein bedeutender Schritt zur Verfügbarkeit von AVT03 in Europa.
Das Unternehmen berichtete kürzlich über positive vorläufige Ergebnisse aus Bestätigungsstudien für AVT03, die eine klinische Ähnlichkeit mit Prolia in Bezug auf Wirksamkeit, Sicherheit, Immunogenität und Pharmakokinetik demonstrieren. Alvotech entwickelt und produziert AVT03 und hat STADA Arzneimittel AG sowie Dr. Reddy's Laboratories SA als kommerzielle Partner in Europa.
Der europäische Denosumab-Markt wird auf etwa 1 Milliarde US-Dollar geschätzt. Der Wettbewerb durch Biosimilars könnte den Zugang der Patienten zu niedrigeren Kosten erhöhen und die erhebliche Belastung durch Osteoporose in Europa angehen, wo etwa 32 Millionen Menschen betroffen sind, aber 70 % der berechtigten Frauen keine Behandlung erhalten.
- EMA acceptance of Marketing Authorization Application for AVT03, a proposed biosimilar to Prolia® and Xgeva®
- Positive topline results from confirmatory patient studies demonstrating clinical similarity of AVT03 to Prolia
- Partnerships with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA for commercialization in Europe
- Potential to expand patient access in a market valued at approximately US$1 billion
- None.
Insights
The EMA's acceptance of Alvotech's marketing application for AVT03, a biosimilar to Prolia® and Xgeva®, is a significant milestone. This development could potentially disrupt the
Key points to consider:
- Positive topline results from clinical trials demonstrate AVT03's similarity to Prolia in efficacy, safety and pharmacokinetics.
- Partnerships with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA for commercialization in Europe indicate strong market potential.
- The European osteoporosis market is underserved, with
70% of eligible women not receiving treatment, presenting a significant growth opportunity. - Biosimilar introduction could expand patient access while potentially reducing healthcare costs in a market with
$63 billion in direct osteoporotic fracture costs.
While this news is positive for Alvotech, investors should monitor the approval process and potential market adoption rates, as well as the competitive landscape in the biosimilar space.
The acceptance of Alvotech's marketing application for AVT03 by the EMA is a pivotal development in addressing healthcare accessibility and affordability in Europe. This move aligns with the growing trend of biosimilar adoption to reduce healthcare costs while maintaining treatment efficacy.
Key implications:
- Potential to significantly reduce the economic burden of osteoporosis treatment in Europe.
- May help address the treatment gap for the estimated 32 million Europeans with osteoporosis.
- Could lead to increased competition in the denosumab market, potentially driving down prices and increasing patient access.
- Demonstrates the importance of biosimilar development in expanding treatment options for chronic conditions.
Policymakers and healthcare systems should prepare for the potential introduction of AVT03, considering its impact on treatment guidelines, reimbursement policies and overall healthcare expenditure. The success of this biosimilar could set a precedent for future biosimilar developments and approvals in Europe.
REYKJAVIK, Iceland, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).
“EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “Successful progression in the development of multiple biosimilar candidates demonstrates how Alvotech is able to leverage its end-to-end biosimilars platform in support of broader access to affordable biologic medicines.”
Alvotech develops and manufactures AVT03. STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA, have entered into agreements with Alvotech for the commercialization of AVT03, each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK.
In July 2024, Alvotech announced positive topline results from a confirmatory patient study for AVT03. The AVT03-GL-C01 study, which met its primary endpoints, demonstrated clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in 532 postmenopausal women with osteoporosis. Primary endpoints were also met in both the AVT03-GL-P01 study, which assessed the PK, safety, and tolerability of AVT03 compared to Prolia in 209 healthy adult participants, and the AVT03-GL-P03 study that assessed the PK, safety, and tolerability of AVT03 compared to Xgeva in 208 healthy adult participants.
Prolia is indicated to treat osteoporosis in postmenopausal women and in men at increased risk of fracture; bone loss in men receiving treatment for prostate cancer that increases their risk of facture; and bone loss in adults at increased risk of fractures who are treated long term with oral or injected corticosteroids [1]. Xgeva is used to prevent bone complications in adults with advanced cancer that has spread to the bone, as well as to treat giant cell tumor of bone in adults and adolescents whose bones have fully developed [2].
Across all indications, the European denosumab market is currently valued at approximately US
In 2019 the total direct cost of osteoporotic fractures in the European Union, Switzerland and UK, was estimated at US
About AVT03 (denosumab)
AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [1]. AVT03 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.
Use of trademarks
Prolia and Xgeva are registered trademarks of Amgen Inc.
Sources
[1] Prolia product information, EMA
[2] Xgeva product information, EMA
[3] IQVIA
[4] Key Statistics for Europe, International Osteoporosis Foundation
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.
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 raise substantial additional funding, which may not be available on acceptable terms or at all; (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
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FAQ
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