Dr. Reddy’s EC Nod for Osteoporosis Biosimilar

has received European Commission marketing authorisation for AVT03, a denosumab biosimilar to Prolia and Xgeva, enabling launches across all EU member states and EEA countries. The decision follows a positive CHMP opinion in September 2025 and is based on analytical, PK/PD, and confirmatory clinical data. Prolia is used to treat osteoporosis and manage fracture risk, while Xgeva addresses bone complications in advanced cancers and giant cell tumour of bone. AVT03, developed and manufactured by Alvotech, will be registered and commercialised by Dr. Reddy’s under a 2024 license-supply agreement, positioning the company for a significant biosimilars revenue opportunity in Europe. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned. ​