Dr. Reddy’s Gains EU Approval for AVT03 Biosimilar of Prolia® and Xgeva®
Filing Summary
Dr. Reddy’s Laboratories Ltd. announced that the European Commission has granted marketing authorization for AVT03, a biosimilar of Prolia® and Xgeva®. This approval allows Dr. Reddy’s to market AVT03 across all EU Member States and EEA countries. The company has an exclusive agreement with Alvotech for the development and manufacturing of AVT03, while Dr. Reddy’s handles registration and commercialization. The biosimilar will be marketed under the names Acvybra® and Xbonzy®. This development is part of Dr. Reddy’s strategy to expand its biosimilars portfolio in the U.S. and Europe.
Dr. Reddy’s Laboratories Ltd. has received marketing authorization from the European Commission for AVT03, a biosimilar of Prolia® and Xgeva®. This approval permits the commercialization of AVT03 across all European Union Member States and European Economic Area countries, including Iceland, Liechtenstein, and Norway. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use in September 2025.
In May 2024, Dr. Reddy’s entered into a license and supply agreement with Alvotech for the commercialization of AVT03. Under this agreement, Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy’s manages registration and commercialization in applicable markets, including the U.S. and Europe. Dr. Reddy’s holds exclusive commercialization rights in the U.S. and semi-exclusive rights in Europe and the UK. The biosimilar will be marketed under the tradenames Acvybra® and Xbonzy®.
The scope of the approval includes the use of AVT03 as a biosimilar to Prolia® and Xgeva®, which are both denosumab-based medications. Prolia® is used for treating osteoporosis in postmenopausal women and men at increased risk of fractures, as well as bone loss linked to hormone ablation in men with prostate cancer. Xgeva® is used to prevent bone complications in adults with advanced cancer involving bone and for treating giant cell tumor of bone in adults and skeletally mature adolescents.
The European Commission’s decision was based on a comprehensive set of data, including analytical comparisons, pharmacokinetic and pharmacodynamic data, and outcomes from a confirmatory clinical trial. This approval is a significant step in Dr. Reddy’s strategy to expand its biosimilars portfolio in key markets, enhancing its presence in the oncology and immunology sectors.
The timeline for the commercialization of AVT03 involves its immediate availability in the approved regions following the European Commission’s authorization. Dr. Reddy’s plans to leverage its existing infrastructure and market presence to facilitate the distribution and sale of AVT03 under the new tradenames.
Alvotech is a biopharmaceutical company focused on the development and manufacturing of biosimilar medicines. The company aims to provide high-quality, cost-effective alternatives to branded biologics, enhancing patient access to essential medications.
Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company committed to providing access to affordable and innovative medicines. The company offers a diverse portfolio of products, including APIs, generics, branded generics, biosimilars, and OTC products. Dr. Reddy’s focuses on major therapeutic areas such as gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology, with significant market presence in the USA, India, Russia, China, Brazil, and Europe.