Hyderabad: Dr Reddy's Laboratories Ltd., has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation for AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab) in European markets. In May 2024, Dr. Reddy’s and Alvotech entered into a license and supply agreement for the commercialization of AVT03. Under the agreement, Alvotech will develop and manufacture AVT03, while Dr. Reddy’s is responsible for registration and commercialization in applicable markets, including the U.S. and Europe. Dr. Reddy’s commercialization rights are exclusive for the U.S., and semi-exclusive for Europe and the UK. AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia and Xgeva, which are both denosumab but in different presentations.