Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia® and Xgeva® (denosumab).
The European denosumab market is currently valued at approximately US$1.2B across all indications, based on originator sales in the last 12 months including the second quarter of 2025. Denosumab is widely used to manage osteoporosis and to prevent skeletal related events in patients with certain cancers. A biosimilar option can help broaden access to these established treatments in Europe.
AVT03 is approved in two presentations: as a biosimilar to Prolia® 60 mg/mL single use pre-filled syringe for the treatment of 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.
“We welcome the European Commission’s approval of AVT03, which demonstrates the continued strength of our end-to-end platform and our ability to deliver high quality biosimilars at scale. This milestone reflects not only the dedication and expertise of our teams, but also the strong partnerships we have built to bring affordable medicines to patients across Europe. Working together, we can help broaden access to essential osteoporosis and oncology supportive care treatments and strengthen the resilience of supply in key markets,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.
The EC decision represents continued progress across Alvotech’s biosimilar portfolio and underscores the company’s role as a longer term partner to health systems across Europe.
In Europe, disabilities due to osteoporosis are greater than those caused by common cancers (with the exception of lung cancer) and comparable to those caused by chronic noncommunicable diseases, such as rheumatoid arthritis, asthma and high blood pressure. Fragility fractures represent a significant economic burden, with incident and prior fragility fractures estimated at €57 billion in 2019.
Biosimilars play an important role in supporting sustainable healthcare budgets across Europe by offering cost-effective treatment options.
In Europe, AVT03 will be commercialized in partnerships with STADA and Dr. Reddy’s, where each partner holds semi-exclusive rights in the EEA, Switzerland and the UK. STADA will market AVT03 as Kefdensis®, biosimilar to Prolia® and as Zvogra®, biosimilar to Xgeva®. Dr. Reddy’s will market AVT03 as Acvybra®, biosimilar to Prolia® and as Xbonzy®, biosimilar to Xgeva®.
The European Commission’s approval of AVT03 as a biosimilar to Prolia and Xgeva was based on a totality of evidence that included comparative analytical, pharmacokinetic and pharmacodynamic data, and data from a confirmatory clinical study. The clinical data package included the PK similarity study AVT03-GL-P01 in healthy adult males (ClinicalTrials.gov identifier NCT05126784) and the comparative efficacy study AVT03-GL-C01 in post menopausal women with osteoporosis (ClinicalTrials.gov identifier NCT05395091) with Prolia used as the reference product in both clinical studies. The results of the clinical studies demonstrate equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product and were reported in peer reviewed publications. Analytical similarity studies also compared AVT03 with both Prolia and Xgeva.
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