A significant stride in the pharmaceutical sector, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has just issued a favorable recommendation. They’ve backed the marketing authorization of AVT03, a promising biosimilar candidate. This drug is the result of a strategic licensing and supply agreement forged last year between Dr. Reddy’s Laboratories and Alvotech.
AVT03 is a biosimilar version of Amgen’s well-known medications, Prolia and Xgeva, both of which contain denosumab in distinct formulations. The positive assessment from the CHMP is now headed to the European Commission. Their final review will determine the official marketing authorization across the European Economic Area, encompassing all European Union nations, as well as Norway, Iceland, and Liechtenstein. Dr. Reddy’s also confirmed that a separate application for marketing authorization will be submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
This venture began in May 2024 when Dr. Reddy’s and Alvotech formalized their partnership through a comprehensive license and supply agreement, specifically for the commercial launch of AVT03. Alvotech’s role is to develop and manufacture the biosimilar, while Dr. Reddy’s takes the lead on its regulatory approval and market distribution in key regions like the U.S. and Europe. Dr. Reddy’s holds exclusive commercialization rights for the U.S. market, with semi-exclusive rights for Europe and the UK. Once approved, the biosimilar will be marketed under two brand names: Acvybra (denosumab) for a 60 mg/mL solution for injection in a pre-filled syringe, and Xbonzy (denosumab) for a 70 mg/mL solution for injection in a vial.
To clarify the original drugs’ uses: Prolia is prescribed for treating osteoporosis in post-menopausal women and men at high risk of fractures, as well as addressing bone loss associated with hormone ablation therapy in men with prostate cancer. Xgeva, on the other hand, is designed to prevent severe bone complications in adults suffering from advanced cancer that has spread to the bones, and also for treating giant cell tumor of bone in adults and skeletally mature adolescents, as detailed in the company’s official announcement.