Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area
Alvotech (NASDAQ: ALVO) announced on November 24, 2025 that the European Commission approved AVT03 as a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area.
AVT03 is approved in two presentations: 60 mg/mL pre-filled syringe for osteoporosis (Prolia) and 70 mg/mL vial for prevention of skeletal related events in advanced malignancies (Xgeva). The European denosumab market is stated at approximately US$1.2 billion in the last 12 months through Q2 2025. Commercialisation in Europe will be via partnerships with STADA and Dr. Reddy’s under semi-exclusive rights.
Alvotech (NASDAQ: ALVO) ha annunciato il 24 novembre 2025 che la Commissione europea ha approvato AVT03 come biosimilare di Prolia e Xgeva (denosumab) nell'Area Economica Europea.
AVT03 è approvato in due confezioni: 60 mg/mL siringa pre-riempita per l'osteoporosi (Prolia) e fiala da 70 mg/mL per la prevenzione degli eventi scheletrici correlati nelle neoplasie avanzate (Xgeva). Il mercato europeo del denosumab è stimato in circa US$1,2 miliardo nell'ultimo periodo di 12 mesi fino al Q2 2025. La commercializzazione in Europa avrà luogo tramite partnership con STADA e Dr. Reddy’s con diritti semi-esclusivi.
Alvotech (NASDAQ: ALVO) anunció el 24 de noviembre de 2025 que la Comisión Europea aprobó AVT03 como biosimilar de Prolia y Xgeva (denosumab) en el Espacio Económico Europeo.
AVT03 está aprobado en dos presentaciones: jeringa precargada de 60 mg/mL para osteoporosis (Prolia) y frasa de 70 mg/mL para la prevención de eventos esqueléticos en neoplasias avanzadas (Xgeva). Se estima que el mercado europeo de denosumab es de aproximadamente US$1,2 mil millones en los últimos 12 meses hasta el segundo trimestre de 2025. La comercialización en Europa será a través de asociaciones con STADA y Dr. Reddy’s bajo derechos semi-exclusivos.
Alvotech (NASDAQ: ALVO)가 2025년 11월 24일에 유럽 위원회가 AVT03를 Prolia 및 Xgeva(데노수맙)의 바이오의약품 모방약으로 승인했다고 발표했습니다. AVT03은 두 가지 제형으로 승인되었습니다: 60 mg/mL 사전 충전 주사기로 골다공증(Prolia) 용, 및 70 mg/mL 바이알로 악성종양 진행 시 골격 관련 사건 예방(Xgeva) 용입니다. 유럽의 데노수맙 시장은 지난 12개월 동안 2025년 2분기까지 약 미화 12억 달러입니다. 유럽 내 상용화는 STADA 및 Dr. Reddy’s와의 파트너십을 통해 반독점적 권리 하에 이루어질 예정입니다.
Alvotech (NASDAQ: ALVO) a annoncé le 24 novembre 2025 que la Commission européenne a approuvé AVT03 en tant que biosimilaire de Prolia et Xgeva (denosumab) dans l’Espace économique européen.
AVT03 est approuvé dans deux présentations : seringue pré-remplie de 60 mg/mL pour l’ostéoporose (Prolia) et flacon de 70 mg/mL pour la prévention des événements ostéo-durables dans les cancers avancés (Xgeva). Le marché européen du denosumab est estimé à environ US$1,2 milliard au cours des 12 derniers mois jusqu’au T2 2025. La commercialisation en Europe se fera via des partenariats avec STADA et Dr. Reddy’s sous des droits semi-exclusifs.
Alvotech (NASDAQ: ALVO) hat am 24. November 2025 bekannt gegeben, dass die Europäische Kommission AVT03 als Biosimilar zu Prolia und Xgeva (Denosumab) im Europäischen Wirtschaftsraum genehmigt hat.
AVT03 ist in zwei Darstellungen zugelassen: 60 mg/mL vorkonfigurierte Spritze zur Osteoporose (Prolia) und 70 mg/mL Flakon zur Prävention von knochenbezogenen Ereignissen bei fortgeschrittenen Malignomen (Xgeva). Der europäische Denosumab-Markt wird auf ca. US$1,2 Mrd. geschätzt in den letzten 12 Monaten bis zum Q2 2025. Die Vermarktung in Europa erfolgt über Partnerschaften mit STADA und Dr. Reddy’s unter semi-exklusiven Rechten.
Alvotech (NASDAQ: ALVO) أعلنت في 24 نوفمبر/تشرين الثاني 2025 أن المفوضية الأوروبية وافقت على AVT03 كم biosimilar لـ Prolia و Xgeva (denosumab) في المنطقة الاقتصادية الأوروبية.
AVT03 معتمَد في شكلين: حقنة مسبقة الملء 60 mg/mL لعلاج هشاشة العظام (Prolia) و قارورة 70 mg/mL للوقاية من الأحداث العظمية المرتبطة بالسرطان المتقدم (Xgeva). السوق الأوروبي للـ denosumab يُقدَّر بنحو 1.2 مليار دولار أمريكي في آخر 12 شهراً حتى الربع الثاني من 2025. ستتم التسويق في أوروبا عبر شراكات مع STADA و Dr. Reddy’s بموجب حقوق شبه حصرية.
- European Commission approval of AVT03 as denosumab biosimilar
- Two approved presentations: 60 mg/mL syringe and 70 mg/mL vial
- Addressable European denosumab market ≈ US$1.2 billion (last 12 months)
- Commercial partnerships with STADA and Dr. Reddy’s for EEA/UK/Switzerland
- None.
Insights
European approval of AVT03 opens a ~
Approval allows AVT03 to be sold in two presentations covering osteoporosis and prevention of skeletal related events, expanding supply options for established indications. Commercialisation via partners STADA and Dr. Reddy’s gives semi-exclusive routes to market across the EEA, Switzerland and the UK, enabling parallel regional launches under local brands.
Market access and uptake will depend on payer acceptance, pricing versus originator volumes, and partner rollout speed; watch initial tender outcomes, national reimbursement decisions, and first commercial launch activity over the next 6–12 months (
Approval rests on a full totality-of-evidence package showing PK/efficacy equivalence and comparable safety and immunogenicity.
The EC decision references comparative analytical, pharmacokinetic, pharmacodynamic and a confirmatory clinical efficacy study, plus peer‑reviewed reports; this aligns with the standard biosimilar pathway and supports interchangeability in many European jurisdictions. The two clinical studies cited used Prolia as the reference and demonstrated equivalent pharmacokinetics and efficacy in the studied populations.
Key near-term milestones to monitor include published detailed study results, product labelling differences, and national regulator guidance on substitution; any unexpected post‑approval safety or immunogenicity signals would materially affect uptake, so surveillance over the first 12 months post‑launch is important.
REYKJAVIK, Iceland, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia® and Xgeva® (denosumab).
The European denosumab market is currently valued at approximately US
AVT03 is approved in two presentations: as a biosimilar to Prolia® 60 mg/mL single use pre-filled syringe for the treatment of osteoporosis and bone loss; and as a biosimilar to Xgeva® 70 mg/mL single use vial for the prevention of skeletal related events in adults with advanced malignancies involving bone.
“We welcome the European Commission’s approval of AVT03, which demonstrates the continued strength of our end-to-end platform and our ability to deliver high quality biosimilars at scale. This milestone reflects not only the dedication and expertise of our teams, but also the strong partnerships we have built to bring affordable medicines to patients across Europe. Working together, we can help broaden access to essential osteoporosis and oncology supportive care treatments and strengthen the resilience of supply in key markets,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.
The EC decision represents continued progress across Alvotech’s biosimilar portfolio and underscores the company’s role as a longer term partner to health systems across Europe.
In Europe, disabilities due to osteoporosis are greater than those caused by common cancers (with the exception of lung cancer) and comparable to those caused by chronic noncommunicable diseases, such as rheumatoid arthritis, asthma and high blood pressure. Fragility fractures represent a significant economic burden, with incident and prior fragility fractures estimated at
Biosimilars play an important role in supporting sustainable healthcare budgets across Europe by offering cost-effective treatment options.
In Europe, AVT03 will be commercialised in partnerships with STADA and Dr. Reddy’s, where each partner holds semi-exclusive rights in the EEA, Switzerland and the UK. STADA will market AVT03 as Kefdensis®, biosimilar to Prolia® and as Zvogra®, biosimilar to Xgeva®. Dr. Reddy’s will market AVT03 as Acvybra®, biosimilar to Prolia® and as Xbonzy®, biosimilar to Xgeva®.
The European Commission’s approval of AVT03 as a biosimilar to Prolia and Xgeva was based on a totality of evidence that included comparative analytical, pharmacokinetic and pharmacodynamic data, and data from a confirmatory clinical study. The clinical data package included the PK similarity study AVT03-GL-P01[3] in healthy adult males (ClinicalTrials.gov identifier NCT05126784) and the comparative efficacy study AVT03-GL-C01[4] in post menopausal women with osteoporosis (ClinicalTrials.gov identifier NCT05395091) with Prolia used as the reference product in both clinical studies. The results of the clinical studies demonstrate equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product and were reported in peer reviewed publications[3,4] . Analytical similarity studies also compared AVT03 with both Prolia and Xgeva.
About AVT03 (denosumab)
AVT03 is a human monoclonal antibody and a biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial), that has been approved for marketing in the EEA and Japan. 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[5].
Use of trademarks
Prolia® and Xgeva® are registered trademarks of Amgen Inc. Kefdensis® and Zvogra® are registered trademarks of STADA Arzneimittel. Acvybra® and Xbonzy® are registered trademarks of Dr. Reddy’s Laboratories SA.
References
[1] IQVIA
[2] Osteoporosis in Europe: a compendium of country-specific reports | Archives of Osteoporosis
[3] Expert Opinion on Investigational Drugs Vol. 34, 2025 – Issue 6
[4] Expert Opinion on Biological Therapy, Vol. 25, 2025 – Issue 8
[5] Prolia product information, EMA
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 established 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
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 include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. 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 factors 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. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. 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.
CONTACT:
Investor Relations and Global Communication
Benedikt Stefansson, VP
alvotech.ir@alvotech.com
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FAQ
What did Alvotech (ALVO) announce on November 24, 2025 about AVT03?
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