Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
Alvotech (NASDAQ: ALVO) and Dr. Reddy's announced that the FDA has accepted their 351(k) Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). The biosimilar aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under their License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in key markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Alvotech (NASDAQ: ALVO) e Dr. Reddy's hanno annunciato che la FDA ha accettato la loro domanda di licenza biologica 351(k) (BLA) per AVT03, un biosimilare proposto per Prolia® e Xgeva® (denosumab). Questo biosimilare è destinato a trattare l'osteoporosi nelle donne in post-menopausa e a prevenire complicazioni ossee nei pazienti oncologici.
In base al loro accordo di licenza e fornitura del maggio 2024, Alvotech si occuperà dello sviluppo e della produzione, mentre Dr. Reddy's gestirà la registrazione e la commercializzazione nei mercati chiave, inclusi gli Stati Uniti. Una volta approvato dalla FDA, AVT03 sarà disponibile in due formulazioni: una siringa pre-riempita monodose da 60 mg/1 mL e un flacone monodose da 120 mg/1.7 mL.
Alvotech (NASDAQ: ALVO) y Dr. Reddy's anunciaron que la FDA ha aceptado su solicitud de licencia biológica 351(k) (BLA) para AVT03, un biosimilar propuesto para Prolia® y Xgeva® (denosumab). Este biosimilar tiene como objetivo tratar la osteoporosis en mujeres posmenopáusicas y prevenir complicaciones óseas en pacientes con cáncer.
Bajo su Acuerdo de Licencia y Suministro de mayo de 2024, Alvotech se encargará del desarrollo y la fabricación, mientras que Dr. Reddy's gestionará el registro y la comercialización en mercados clave, incluidos los EE. UU. Una vez aprobado por la FDA, AVT03 estará disponible en dos formulaciones: una jeringa precargada de dosis única de 60 mg/1 mL y un vial de dosis única de 120 mg/1.7 mL.
Alvotech (NASDAQ: ALVO)와 Dr. Reddy's는 FDA가 AVT03에 대한 351(k) 생물학적 라이센스 신청(BLA)을 수락했다고 발표했습니다. 이는 Prolia® 및 Xgeva®(데노수맙)의 제안된 바이오시밀러입니다. 이 바이오시밀러는 폐경 후 여성의 골다공증 치료 및 암 환자의 골합병증 예방을 목표로 하고 있습니다.
2024년 5월의 라이센스 및 공급 계약에 따라 Alvotech는 개발 및 제조를 담당하고, Dr. Reddy's는 미국을 포함한 주요 시장에서 등록 및 상업화를 관리합니다. FDA 승인이 이루어지면 AVT03은 60 mg/1 mL 단일 용량 프리필드 주사기와 120 mg/1.7 mL 단일 용량 바이알의 두 가지 제형으로 제공될 예정입니다.
Alvotech (NASDAQ: ALVO) et Dr. Reddy's ont annoncé que la FDA a accepté leur demande de licence biologique 351(k) (BLA) pour AVT03, un biosimilaire proposé pour Prolia® et Xgeva® (dénosumab). Ce biosimilaire vise à traiter l'ostéoporose chez les femmes post-ménopausées et à prévenir les complications osseuses chez les patients atteints de cancer.
Dans le cadre de leur accord de licence et de fourniture de mai 2024, Alvotech s'occupera du développement et de la fabrication, tandis que Dr. Reddy's gérera l'enregistrement et la commercialisation sur des marchés clés, y compris les États-Unis. Une fois approuvé par la FDA, AVT03 sera disponible en deux formulations : une seringue préremplie de 60 mg/1 mL et un flacon de 120 mg/1.7 mL.
Alvotech (NASDAQ: ALVO) und Dr. Reddy's haben angekündigt, dass die FDA ihren Antrag auf biologische Lizenz 351(k) (BLA) für AVT03, ein vorgeschlagener Biosimilar zu Prolia® und Xgeva® (Denosumab), akzeptiert hat. Das Biosimilar zielt darauf ab, Osteoporose bei postmenopausalen Frauen zu behandeln und Knochenschäden bei Krebspatienten vorzubeugen.
Im Rahmen ihres Lizenz- und Liefervertrags vom Mai 2024 wird Alvotech die Entwicklung und Herstellung übernehmen, während Dr. Reddy's die Registrierung und Vermarktung in wichtigen Märkten, einschließlich der USA, verwalten wird. Nach der Genehmigung durch die FDA wird AVT03 in zwei Formulierungen erhältlich sein: einer 60 mg/1 mL Einzeldosis- Fertigspritze und einem 120 mg/1.7 mL Einzeldosis-Vial.
- FDA acceptance of BLA submission represents significant regulatory milestone
- Partnership with established pharma company Dr. Reddy's for commercialization
- Targeting large market opportunities in osteoporosis and oncology
- None.
Insights
The FDA's acceptance of Alvotech's Biologic License Application (BLA) for AVT03 represents a significant regulatory milestone in the company's development pipeline. This proposed denosumab biosimilar targets two established reference products with substantial market value - Prolia® and Xgeva® - which collectively generate several billion dollars in annual revenue for Amgen.
This acceptance initiates the FDA's formal review process, typically lasting 10-12 months for biosimilars, positioning Alvotech for potential commercialization in 2026 if approved. The strategic partnership with Dr. Reddy's creates a complementary value chain where Alvotech handles development and manufacturing while Dr. Reddy's manages commercialization, leveraging their established market presence.
For Alvotech investors, this milestone reduces regulatory risk for an important pipeline asset. While FDA acceptance doesn't guarantee approval, it confirms the application meets basic requirements for comprehensive review. The denosumab opportunity aligns with Alvotech's specialized biosimilar strategy, potentially adding a significant commercial product to their portfolio.
The structured agreement with Dr. Reddy's suggests revenue-sharing terms typical of such partnerships, though specific economics weren't disclosed. The dual indications for osteoporosis and oncology provide market diversification, enhancing the commercial potential compared to single-indication biosimilars.
The FDA's acceptance of AVT03's Biologic License Application represents meaningful progress toward potentially expanding patient access to denosumab therapy. The original biologics - Prolia® and Xgeva® - address significant clinical needs across multiple patient populations, including postmenopausal women with osteoporosis and cancer patients with bone metastases.
Denosumab functions as a RANKL inhibitor (receptor activator of nuclear factor kappa-B ligand), preventing osteoclast formation and reducing bone resorption. This mechanism provides effective treatment for conditions with increased bone turnover and fragility. The biosimilar development process requires demonstrating highly similar clinical efficacy, safety, and immunogenicity profiles to the reference products.
If approved, AVT03 would be supplied in identical formulations to the reference products: a 60mg/1mL prefilled syringe (Prolia equivalent) and 120mg/1.7mL vial (Xgeva equivalent). This dual presentation strategy allows targeting both the osteoporosis market, where Prolia dominates, and the oncology setting, where Xgeva is standard care for preventing skeletal-related events.
Biosimilar introduction typically improves healthcare economics while maintaining clinical outcomes. For patients, particularly those with insurance coverage or high deductibles, a denosumab biosimilar could significantly reduce out-of-pocket costs for these chronic or life-extending therapies.
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”) and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab).
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan Kalawadia, Chief Executive Officer, Dr. Reddy’s North America.
“This milestone marks an important step in our mission to improve patient lives by expanding access to affordable and quality biologic medicines. We look forward to being able to serve the large population of patients requiring treatment for osteoporosis and other diseases of the bone,” said Joseph McClellan, Chief Scientific Officer for Alvotech.
Prolia® is a prescription biologic medicine used to treat osteoporosis in women after menopause who are at high risk for bone fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well [1]. Xgeva® is a prescription biologic medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors [2].
In May 2024, Dr. Reddy’s and Alvotech entered into a License and Supply Agreement for AVT03. Under the agreement, Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy’s is responsible for registration and commercialization in applicable markets, including the U.S. After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.
About AVT03
AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations. Prolia® is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture [1]. Xgeva® is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone [2]. 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.
References
[1] Amgen Inc. Prolia® (Denosumab): Prescribing Information. Downloaded from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf
[2] Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Downloaded from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf
Use of trademarks
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
About Dr. Reddy’s Laboratories Ltd:
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
For more information, log on to: www.drreddys.com.
Dr. Reddy’s Disclaimer
This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein.
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
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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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DR. REDDY’S CONTACTS
| Usha Iyer Head of Corporate Communications ushaiyer@drreddys.com | Richa Periwal Head of Investor Relations richaperiwal@drreddys.com |
ALVOTECH CONTACTS
Benedikt Stefansson
VP of Investor Relations and Global Communications
alvotech.ir@alvotech.com
FAQ
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