Dr Reddy’s Laboratories Ltd has received marketing authorization from the European Commission for AVT03, its biosimilar version of denosumab used in Prolia® and Xgeva®. Prolia® is prescribed for treating osteoporosis in postmenopausal women and men at higher fracture risk, as well as bone loss caused by hormone therapy or long-term glucocorticoid use. Xgeva® is used to prevent skeletal-related events in adults with advanced cancers that have spread to bone, and to treat giant cell tumour of bone in adults and skeletally mature adolescents.
The approval follows a positive recommendation issued by the Committee for Medicinal Products for Human Use (CHMP) in September 2025. The decision is supported by extensive data, including analytical comparisons, pharmacokinetic and pharmacodynamic evidence, and results from a confirmatory clinical study. The authorization applies across all EU member nations and the EEA markets of Norway, Iceland, and Liechtenstein.
In May 2024, Dr Reddy’s entered into a licensing and supply arrangement with Alvotech for the development and production of AVT03. Under the partnership, Alvotech will handle manufacturing, while Dr Reddy’s oversees regulatory submissions and commercialization in multiple regions. The company holds exclusive rights for the U.S. and semi-exclusive rights for Europe and the UK. Once commercialized, the biosimilar will be distributed under the brands Acvybra® (60 mg/mL pre-filled syringe) and Xbonzy® (70 mg/mL vial).
AVT03 is a human monoclonal IgG2 antibody designed as a biosimilar to both Prolia® and Xgeva®, which share the same active ingredient, denosumab, in different formulations. Denosumab works by binding to the RANK ligand, preventing its interaction with the RANK receptor. This action reduces osteoclast formation and activity, thereby lowering bone resorption and cancer-associated bone damage.
Dr Reddy’s Laboratories, founded in 1984 and headquartered in Hyderabad, is a multinational pharmaceutical company focused on improving access to effective and affordable treatments. Its portfolio spans APIs, generics, branded generics, biosimilars, and consumer health products across major therapeutic areas such as oncology, gastroenterology, diabetology, cardiovascular diseases, dermatology, and pain management. The company serves key markets including the U.S., India, Europe, China, Brazil, and the CIS region.
With more than two decades of experience in biologics, Dr Reddy’s has built comprehensive end-to-end capabilities for biosimilar development and commercialization. It currently markets six biosimilars in India and over 30 countries, with several more in the pipeline across oncology and autoimmune diseases. The company continues to scale its manufacturing footprint and expand globally, marked by recent launches such as Versavo® in the UK and pegfilgrastim in the U.S. and Europe through partner collaborations. Its biosimilars division remains a central growth driver for both immediate and long-term strategic ambitions.
