The European Medical Agency’s (EMA) committee has recommended AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab), for marketing authorization in the European Economic Area (EEA). The positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) will now be reviewed by the European Commission, which will make a decision on granting marketing authorization. A separate application will be submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure.
AVT03 is a biosimilar version of denosumab, which is used to treat various bone-related conditions, including osteoporosis in postmenopausal women and men, bone loss linked to hormone ablation in men with prostate cancer, and bone complications in adults with advanced cancer. The biosimilar will be commercialized by Dr. Reddy’s, which has exclusive rights in the US and semi-exclusive rights in Europe and the UK.
In May 2024, Dr. Reddy’s entered into a license and supply agreement with Alvotech, under which Alvotech will develop and manufacture AVT03, while Dr. Reddy’s will handle registration and commercialization. Upon approval, Dr. Reddy’s will market the biosimilar under the trade names Acvybra (denosumab) solution for injection in a pre-filled syringe and Xbonzy (denosumab) solution for injection in a vial.
The recommendation from the EMA’s CHMP is a significant step towards making AVT03 available to patients in Europe. The biosimilar is expected to provide a more affordable alternative to the reference products, Prolia and Xgeva, which are used to treat a range of bone-related conditions. Dr. Reddy’s plans to commercialize the biosimilar in the US, Europe, and the UK, subject to regulatory approvals.
The commercialization of AVT03 is expected to have a significant impact on the market for denosumab, which is a widely used medication for the treatment of osteoporosis and other bone-related conditions. The availability of a biosimilar version of denosumab is expected to increase access to this important medication, particularly for patients who may not have been able to afford the reference product. With the recommendation from the EMA’s CHMP, Dr. Reddy’s is one step closer to launching AVT03 in Europe, which is expected to be a significant milestone for the company.