European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®
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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