European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®
Alvotech (NASDAQ: ALVO) has received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, its proposed biosimilar to Prolia® and Xgeva® (denosumab).
Upon approval, the biosimilar will be marketed by STADA Arzneimittel AG and Dr. Reddy's Laboratories SA with semi-exclusive commercial rights in Europe, including Switzerland and the UK. The biosimilar will be available in two formulations: a 60 mg/mL pre-filled syringe and a 70 mg/mL vial, targeting conditions including osteoporosis in postmenopausal women, bone loss in cancer patients, and giant cell tumor of bone.
Alvotech (NASDAQ: ALVO) ha ricevuto una raccomandazione positiva dall'EMA's CHMP per AVT03, il biosimilare proposto a Prolia® e Xgeva® (denosumab).
In caso di approvazione, il biosimilare sarà commercializzato da STADA Arzneimittel AG e Dr. Reddy's Laboratories SA con diritti commerciali semi-esclusivi in Europa, inclusa Svizzera e Regno Unito. Il biosimilare sarà disponibile in due formulazioni: una siringa pre-riempita da 60 mg/mL e un flacone da 70 mg/mL, mirate a condizioni quali osteoporosi nelle donne in postmenopausa, perdita ossea nei pazienti oncologici e tumore a cellule giganti dell'osso.
Alvotech (NASDAQ: ALVO) ha recibido una recomendación positiva de la CHMP de la Agencia Europea de Medicamentos (EMA) para AVT03, su biosimilar propuesto a Prolia® y Xgeva® (denosumab).
Una vez aprobado, el biosimilar será comercializado por STADA Arzneimittel AG y Dr. Reddy's Laboratories SA con derechos comerciales semi-exclusivos en Europa, incluyendo Suiza y el Reino Unido. El biosimilar estará disponible en dos formulaciones: una jeringa prellenada de 60 mg/mL y un vial de 70 mg/mL, dirigido a indicaciones como osteoporosis en mujeres posmenopáusicas, pérdida ósea en pacientes con cáncer y tumor de células gigantes de hueso.
Alvotech (NASDAQ: ALVO)가 유럽의약품청(EMA) 의약품인간사용위원회(CHMP)로부터 AVT03에 대한 긍정적 권고를 받았습니다. 이는 프로리아(Prolia)와 Xgeva(denosumab)의 바이오시밀러로 제안됩니다.
승인 시, 이 바이오시밀러는 STADA Arzneimittel AG와 Dr. Reddy's Laboratories SA가 유럽(스위스 및 영국 포함)에서 반독점적 반독점적 상업권을 갖고 판매됩니다. 두 가지 제형으로 제공되며, 60 mg/mL의 프리필드 주사기와 70 mg/mL의 바이알 형태로, 폐경 후 여성의 골다공증, 암 환자의 골손실, 골수 거대세포종 등을 목표로 합니다.
Alvotech (NASDAQ: ALVO) a reçu une recommandation positive du CHMP de l’EMA pour AVT03, son biosimilaire proposé à Prolia® et Xgeva® (denosumab).
En cas d’approbation, le biosimilaire sera commercialisé par STADA Arzneimittel AG et Dr. Reddy's Laboratories SA avec des droits commerciaux semi-exclusifs en Europe, y compris la Suisse et le Royaume‑Uni. Le biosimilaire sera disponible en deux formulations : une seringue pré-remplie de 60 mg/mL et un flacon de 70 mg/mL, destiné à des indications telles que l’ostéoporose chez les femmes ménopausées, la perte osseuse chez les patients atteints de cancer et la tumeur à grandes cellules osseuses.
Alvotech (NASDAQ: ALVO) hat eine positive Empfehlung des CHMP der EMA für AVT03 erhalten, sein vorgeschlagenes Biosimilar zu Prolia® und Xgeva® (Denosumab).
Bei Genehmigung wird das Biosimilar von STADA Arzneimittel AG und Dr. Reddy's Laboratories SA mit semiexklusiven Vermarktungsrechten in Europa, einschließlich der Schweiz und dem Vereinigten Königreich, vermarktet werden. Das Biosimilar wird in zwei Formulierungen verfügbar sein: eine 60 mg/mL-Fertigspritze und eine 70 mg/mL-Vial, vorgesehen für Indikationen wie Osteoporose bei postmenopausalen Frauen, Knochenverlust bei Krebspatienten und der Riesenzellknochentumor.
Alvotech (NASDAQ: ALVO) تحصلت على توصية إيجابية من اللجنة المعنية بالمنتجات الدوائية للاستخدام البشري (CHMP) التابعة لهيئة الدواء الأوروبية (EMA) لـ AVT03، وهو بيـوسيمـيلـر مقترح لـ Prolia و Xgeva (Denosumab).
عند الموافقة، سيُطرح البيوسيميلر من قبل STADA Arzneimittel AG وDr. Reddy's Laboratories SA بحقوق تجارية شبه حصرية في أوروبا، بما في ذلك سويسرا والمملكة المتحدة. سيكون البيوسيميلر متاحاً في شكلين: حقنة مُعبأة مسبقاً بتركيز 60 mg/mL وقنينة بتركيز 70 mg/mL، مستهدفاً حالات مثل هشاشة العظام لدى النساء بعد سن اليأس، فقدان العظم لدى مرضى السرطان، وسرطان الخلايا العَرْقية العظمية.
Alvotech (NASDAQ: ALVO) 已从欧洲药品管理局（EMA）的药品人用用药委员会（CHMP）获得对 AVT03 的积极意见，这是其拟议的仿制药，针对 Prolia® 和 Xgeva®（Denosumab）。
一旦获批，该生物仿制药将由 STADA Arzneimittel AG 和 Dr. Reddy's Laboratories SA 以半独占的商业权在欧洲（包括瑞士和英国）销售。该生物仿制药将提供两种剂型：60 mg/mL 的预填充注射器和 70 mg/mL 的瓶剂，适用于绝经后女性的骨质疏松、癌症患者的骨丢失，以及骨巨细胞瘤等适应症。
- Positive CHMP recommendation increases likelihood of European approval
- Partnership with established companies STADA and Dr. Reddy's for European commercialization
- Targets multiple indications including osteoporosis and oncology-related bone complications
- Demonstrates company's capability in biosimilar development and manufacturing
- Final EMA approval still pending
- Will face competition from established branded products Prolia® and Xgeva®
Insights
EMA recommendation for Alvotech's denosumab biosimilar signals imminent European market entry, boosting commercial prospects through established partnerships.
The CHMP positive opinion for Alvotech's denosumab biosimilar (AVT03) represents a critical regulatory milestone that substantially increases the likelihood of European Commission approval. This development positions Alvotech to enter the valuable European market for two significant indications - osteoporosis (Prolia) and bone complications in cancer patients (Xgeva).
The strategic partnership structure with STADA and Dr. Reddy's for semi-exclusive commercial rights throughout Europe creates an efficient market entry pathway without Alvotech needing to build its own European sales infrastructure. Each partner will market the product under different brand names - STADA using Kefdensis and Zvogra, while Dr. Reddy's will use Acvybra and Xbonzy.
Denosumab biosimilars represent an important market opportunity as the reference products address conditions with substantial patient populations. Prolia targets osteoporosis in postmenopausal women and men with fracture risk, while Xgeva addresses bone complications in advanced cancer and giant cell tumor of bone. The original products generate significant revenue, and biosimilar entry typically creates market expansion through improved affordability and access.
This recommendation demonstrates the effectiveness of Alvotech's integrated platform approach to biosimilar development, highlighting their ability to navigate complex regulatory pathways for monoclonal antibodies. The company's focused business model as a pure-play biosimilar developer continues to show validation through regulatory advancement.
REYKJAVIK, Iceland, Sept. 22, 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 Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03, Alvotech’s proposed biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial). Pending approval, the biosimilar will be marketed by Alvotech’s commercial partners, STADA Arzneimittel AG (“STADA”) and Dr. Reddy’s Laboratories SA (“Dr. Reddy’s”), each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK.
“We look forward to working with our partners in making denosumab available more widely to patients and caregivers. This important step demonstrates how Alvotech specialization in biosimilars development and manufacture and integrated end-to-end platform enables broader access to affordable biologic medicines.” said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.
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].
AVT03 remains under EMA regulatory review with a final decision by the European Commission pending. Upon approval, STADA will offer the biosimilar under the tradenames Kefdensis® (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Zvogra® (denosumab) 70 mg/mL solution for injection in a vial, while the corresponding tradenames for Dr. Reddy’s are Acvybra® (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy® (denosumab) 70 mg/mL solution for injection in a vial.
About AVT03
AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial). 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. Kefdensis® and Zvogra® are registered trademarks of STADA Arzneimittel AG. Acvybra® and Xbonzy® are registered trademarks of Dr. Reddy’s Laboratories Ltd.
Sources
[1] Prolia product information, EMA
[2] Xgeva 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 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 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. 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