India Pharma Outlook Team | Tuesday, 25 November 2025
The European Commission has approved the denosumab biosimilar AVT03 marketing. This license allows the Dr.?Reddy’s Laboratories to provide new options of treatment all over the EU and the European Economic Area.
The jurisdiction encompasses the 27 EU countries plus Iceland, Liechtenstein, and Norway, whichis a milestone not only of the company but also of the biosimilar market of the region.
This is based on a favorable CHMP opinion that was adopted in September 2025. It is based on an extensive package of evidence, such as analytical studies, PK/PD information, and findings of a confirmatory clinical trial. AVT03 is the biosimilar of the Amgen Prolia (denosumab 60 ?mg/mL) and Xgeva (denosumab 70 ?mg/mL), popular with the serious bone-related diseases.
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Prolia is used as a treatment of osteoporosis in post menopausal women and in men who have a high risk of fracture. It is also used to deal with bone loss due to hormone-ablation therapy in prostate cancer and long-term use of glucocorticoids. Xgeva is used to prevent skeletal complications in adults with advanced bone involving cancers and to treat giant cell tumor of bone in adults and skeletally mature adolescents.
Dr. Reddy under license and supply deal with Alvotech, which is the developer and manufacturer of AVT03, has a commercialization right of the drug in major markets such as Europe and the United States. The company will commercially sell the biosimilar under two brand names: Acvybra (denosumab 60mg/mL in a pre-filled syringe) and Xbonzy (denosumab 70mg/mL in a vial) depending on the country of sale.
The European biologics market will also become competitive with the introduction of this denosumab biosimilar and is projected to expand access to vital bone-health treatments in the region.
