AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia and Xgeva, which are both denosumab but in different presentations.
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 used to prevent bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
The EC decision is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
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.
Hyderabad-based Dr. Reddy’s Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.
The company’s consolidated net profit jumped 7.3% to Rs 1,347.10 crore on 9.8% increase in revenue from operations to Rs 8,804.90 crore in Q2 FY26 over Q2 FY25.