Alvotech and Dr. Reddy’s Announce FDA Acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), jointly announced by Dr. Reddy's Laboratories and Alvotech. AVT03 aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under a License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in applicable 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.
La FDA ha accettato una domanda di licenza biologica (BLA) per AVT03, un biosimilare proposto per Prolia® e Xgeva® (denosumab), annunciato congiuntamente da Dr. Reddy's Laboratories e Alvotech. AVT03 mira a trattare l'osteoporosi nelle donne in post-menopausa e a prevenire complicazioni ossee nei pazienti oncologici.
In base a un accordo di licenza e fornitura di maggio 2024, Alvotech si occuperà dello sviluppo e della produzione, mentre Dr. Reddy's gestirà la registrazione e la commercializzazione nei mercati applicabili, inclusi gli Stati Uniti. Una volta approvato dalla FDA, AVT03 sarà disponibile in due formulazioni: una siringa pre-riempita da 60 mg/1 mL e un flacone monodose da 120 mg/1.7 mL.
La FDA ha aceptado una Solicitud de Licencia Biológica (BLA) para AVT03, un biosimilar propuesto para Prolia® y Xgeva® (denosumab), anunciado conjuntamente por Dr. Reddy's Laboratories y Alvotech. AVT03 tiene como objetivo tratar la osteoporosis en mujeres posmenopáusicas y prevenir complicaciones óseas en pacientes con cáncer.
Según un 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 los mercados aplicables, incluidos los EE.UU. Tras la aprobación de la FDA, AVT03 estará disponible en dos formulaciones: una jeringa precargada de 60 mg/1 mL y un vial de dosis única de 120 mg/1.7 mL.
FDA가 AVT03에 대한 생물학적 제품 허가 신청(BLA)을 승인했습니다. AVT03는 Prolia® 및 Xgeva®(데노수맙)의 제안된 바이오시밀러로, Dr. Reddy's Laboratories와 Alvotech이 공동 발표했습니다. AVT03는 폐경 후 여성의 골다공증 치료와 암 환자의 뼈 합병증 예방을 목표로 합니다.
2024년 5월의 라이선스 및 공급 계약에 따라, Alvotech가 개발 및 제조를 담당합니다, 반면 Dr. Reddy's는 해당 시장에서의 등록 및 상업화를 관리합니다, 미국을 포함하여. FDA 승인이 나면 AVT03는 두 가지 제형으로 제공됩니다: 60 mg/1 mL 단일 용량의 프리필드 주사기와 120 mg/1.7 mL 단일 용량의 바이알입니다.
La FDA a accepté une Demande de Licence Biologique (BLA) pour AVT03, un biosimilaire proposé à Prolia® et Xgeva® (dénosumab), annoncé conjointement par Dr. Reddy's Laboratories et Alvotech. AVT03 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 d'un Accord de Licence et de Fourniture à partir de mai 2024, Alvotech s'occupera du développement et de la fabrication, tandis que Dr. Reddy's gérera l'enregistrement et la commercialisation sur les marchés concernés, 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 dose unique de 120 mg/1,7 mL.
Die FDA hat einen Antrag auf biologische Lizenz (BLA) für AVT03 akzeptiert, ein vorgeschlagenes Biosimilar zu Prolia® und Xgeva® (Denosumab), das gemeinsam von Dr. Reddy's Laboratories und Alvotech angekündigt wurde. AVT03 zielt darauf ab, Osteoporose bei postmenopausalen Frauen zu behandeln und Knochenschäden bei Krebspatienten zu verhindern.
Im Rahmen eines Lizenz- und Liefervertrags ab Mai 2024 wird Alvotech die Entwicklung und Herstellung übernehmen, während Dr. Reddy's die Registrierung und Kommerzialisierung in den relevanten Märkten, einschließlich der USA, übernimmt. 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-Fläschchen.
- FDA acceptance of BLA submission represents significant regulatory progress
- Partnership structure clearly defined with complementary responsibilities
- Two different dosage forms planned for market flexibility
- Timeline for potential FDA approval not specified
- Market size and revenue potential not disclosed
Insights
The FDA's acceptance of the Biologic License Application (BLA) for AVT03 represents a significant regulatory milestone for Dr. Reddy's biosimilar strategy. This acceptance initiates the formal review process for their proposed biosimilar to denosumab, marketed as Prolia® and Xgeva® by Amgen.
Denosumab represents a substantial market opportunity. The reference products address two major therapeutic areas: osteoporosis in postmenopausal women (Prolia) and prevention of skeletal-related events in cancer patients (Xgeva). Combined annual sales of these products exceed
This advancement follows Dr. Reddy's May 2024 licensing agreement with Alvotech, with a clear division of responsibilities: Alvotech handles development and manufacturing while Dr. Reddy's manages registration and commercialization. This partnership structure optimally leverages each company's core competencies.
The regulatory pathway for biosimilars typically takes 10-12 months from BLA acceptance to approval decision. If approved, AVT03 would strengthen Dr. Reddy's position in the high-value biosimilar market and potentially generate meaningful revenue in commercially important therapeutic areas where patient access remains challenging due to cost barriers.
This milestone indicates the application contained sufficient quality data to warrant substantive review, though final approval remains contingent on demonstrating biosimilarity to the reference products.
The FDA's acceptance of the AVT03 BLA strengthens Dr. Reddy's position in the high-growth biosimilar sector. This development has strategic significance beyond the immediate news, as it demonstrates execution on their partnership-based biosimilar strategy.
The denosumab opportunity targets two distinct and valuable market segments. Prolia addresses the osteoporosis market, which continues expanding due to aging demographics and undertreatment patterns. Xgeva serves oncology patients with bone metastases, representing a critical component of supportive care in cancer treatment.
The Alvotech partnership exemplifies Dr. Reddy's capital-efficient approach to biosimilar development. Rather than bearing the full
Looking at market dynamics, denosumab biosimilars face fewer barriers to adoption compared to some other biologics. The products don't require the intensive physician supervision characteristic of infused oncology products, potentially enabling faster market uptake following approval.
The dual formulation approach mentioned in the release - offering both the 60mg prefilled syringe and 120mg single-dose vial - indicates preparations for addressing both market segments (osteoporosis and oncology), maximizing the commercial potential if approved.
“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
“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
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
- Amgen Inc. Prolia® (Denosumab): Prescribing Information. Downloaded from: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf
- 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
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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
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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 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
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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
Source: Dr. Reddy’s Laboratories Ltd.
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