The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab), for marketing authorisation. The CHMP’s positive opinion will now move to the European Commission (EC) for final review. Once approved, AVT03 will be authorised for use across the European Economic Area (EEA), covering all EU member states as well as Norway, Iceland, and Liechtenstein.
UK Submission Planned Separately
In line with the International Recognition Procedure (IRP), a separate Marketing Authorisation Application (MAA) will be filed with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Target Indications: Prolia and Xgeva Equivalents
Doctors prescribe Prolia to treat osteoporosis in postmenopausal women and men at increased risk of fractures, as well as bone loss from hormone ablation in men with prostate cancer and long-term systemic glucocorticoid treatment. Doctors use Xgeva to prevent bone complications in adults with advanced cancers involving bone and to treat giant cell tumour of bone in adults and skeletally mature adolescents. Once authorised, AVT03 will provide a cost-effective biosimilar alternative to both medicines.
Partnership with Alvotech
Dr. Reddy’s Laboratories entered into a license and supply agreement with Alvotech in May 2024. Under this partnership:
*Alvotech will develop and manufacture AVT03.
*Dr. Reddy’s will handle registration and commercialization in key markets, including the U.S. and Europe.
*Dr. Reddy’s holds exclusive commercialization rights in the U.S. and semi-exclusive rights in Europe and the UK.
Future Commercialization Plans
Upon approval, Dr. Reddy’s will market the biosimilar under two trade names:
*Acvybra (denosumab) – solution for injection in a pre-filled syringe.
*Xbonzy (denosumab) – solution for injection in a vial.
Strengthening Global Biosimilar Portfolio
As reported by thehindubusinessline.com, the recommendation marks another milestone in Dr. Reddy’s effort to expand its global biosimilars portfolio. It offers affordable, high-quality alternatives to critical therapies and supports wider patient access to advanced treatments.
