Alvotech (ALVO) announced that the European Commission has approved AVT03, a biosimilar to Amgen's Prolia and Xgeva for use across Europe.
Prolia is indicated to treat osteoporosis and bone loss in postmenopausal women and in men at increased risk of fracture and adults on long-term corticosteroid therapy. Xgeva is used to prevent bone complications in advanced cancers that spread to bone and treat giant cell tumor of bone in adults and adolescents with mature skeletons.
Both Prolia and Xgeva contain the active ingredient denosumab.
Denosumab is widely prescribed to manage osteoporosis and to prevent skeletal-related events in patients with certain cancers. The European denosumab market is valued at approximately $1.2 billion annually, underscoring the significance of a lower-cost biosimilar option.
AVT03 is approved in two presentations: as a biosimilar to Prolia (60 mg/mL single-use pre-filled syringe) for 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.
The approval was supported by a comprehensive data package, including comparative analytical studies, pharmacokinetic and pharmacodynamic evaluations, and a confirmatory trial. Results demonstrated equivalent efficacy, safety, and immunogenicity compared to the reference products.
Commercialization in Europe will be handled through partnerships:
STADA will market AVT03 as Kefdensis (biosimilar to Prolia) and as Zvogra (biosimilar to Xgeva), while Dr. Reddy's will market it as Acvybra (biosimilar to Prolia) and as Xbonzy (biosimilar to Xgeva).
"This approval reflects the strength of our end-to-end biosimilar platform and our ability to deliver high-quality medicines at scale," said Robert Wessman, Chairman and CEO of Alvotech. He added that the milestone will broaden access to essential osteoporosis and oncology supportive care treatments across Europe.
In addition to the European approval, AVT03 was approved in Japan in September 2025 as DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection, a biosimilar to Ranmark.
In the U.S., the FDA accepted the 351(k) Biologics License Application (BLA) for AVT03 in March 2025, submitted jointly by Alvotech and Dr. Reddy's. The filling covers all indications of Prolia and Xgeva, with Alvotech responsible for development and manufacturing and Dr. Reddy's handling registration and commercialization.
The EU commission's decision marks continued progress in Alvotech's biosimilar portfolio, which already includes approved biosimilars to Humira and Stelara.
ALVO has traded in the range of $4.70 to $13.70 over the past year. The stock closed Friday's trading at $5.14, up 1.58%.
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