Interchangeable biosimilars to Prolia and Xgeva target osteoporosis and cancer-related bone complications in a $5 billion U.S. market
The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo and Evfraxy) in Europe starting December 2, 2025
AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions
Prolia is a prescription medicine used to treat osteoporosis in women
Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints
Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
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