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Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today 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$1.2 billion across all indications, based on originator sales in the last 12 months including the second quarter of 2025[1]. 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.
Posted In: ALVO
