Dr. Reddy’s Gets European Commission Approval for AVT03, a Biosimilar to Prolia & Xgeva

Dr. Reddy’s Laboratories has received **European Commission (EC) approval** for **AVT03 (denosumab)**, its proposed biosimilar to **Prolia® and Xgeva®**, marking a significant milestone in its global biosimilar strategy. The clearance—valid across all EU and EEA countries—follows a positive CHMP opinion and is supported by extensive analytical, PK/PD, and clinical data. Under its partnership with Alvotech, Alvotech will manufacture AVT03, while Dr. Reddy’s will handle registration and commercialization in key markets, including the **US and Europe**. The product will be launched under the brands **Acvybra®** and **Xbonzy®**. The approval strengthens Dr. Reddy’s position in high-growth biologics, aligning with its long-term global expansion roadmap. **Disclaimer:** This is for informational purposes, not investment advice. **Follow for more:** Daily business & market updates.