Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its proposed biosimilar of Prolia® and Xgeva® (denosumab). The application, AVT03, aims to address osteoporosis and bone complications. This opinion will be reviewed by the European Commission for marketing authorization in the European Economic Area. Commercialization rights are exclusive for the U.S. and semi-exclusive for Europe and the UK.
European Regulatory Milestone
Dr. Reddy’s Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for AVT03 (denosumab), a biosimilar of Prolia® and Xgeva®. This announcement was made on September 22, 2025.
AVT03: Proposed Biosimilar
AVT03 is a proposed biosimilar of denosumab, referencing Prolia® and Xgeva®. Prolia® is used to treat osteoporosis in women who have gone through menopause and men at increased risk of fractures. Xgeva® prevents bone complications in adults with advanced cancer involving bone and treats adults and skeletally mature adolescents with giant cell tumor of bone.
Commercialization Strategy
Dr. Reddy’s and Alvotech have a license and supply agreement for AVT03. Alvotech will develop and manufacture AVT03, while Dr. Reddy’s will handle registration and commercialization in applicable markets, including the U.S. and Europe. Dr. Reddy’s has exclusive commercialization rights for the U.S. and semi-exclusive rights for Europe and the UK.
Future Availability
Upon approval, Dr. Reddy’s intends to offer the biosimilar under the tradenames Acvybra® (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy® (denosumab) 70 mg/mL solution for injection in a vial.
Source: BSE
