Dr. Reddy's Laboratories Ltd. announced that the European Commission (EC) has granted marketing authorization for AVT03, a biosimilar of Prolia®? (denosumab) and Xgeva (denosUMab). Prolia is a prescription medicine used to treat osteoporosis in women who have been through menopause and in men who are at increased risk of fractures, bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term treatment with systemic glucocorticoid.
Xgeva is a prescription medicine use to treat osteoporosis 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.
Upon approval Dr. Reddy's will offer the biosimilar under the tradenames Acvybra (denosumAB) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy (denosum AB) 70 mg/mL solution for injection In a vial. AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia and Xgeva, which are both denosumab but in different presentations. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.
