Dr Reddy’s Laboratories has received marketing approval from the European Commission (EC) for AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab) prescribed in the treatment of bone related conditions, the company said in a statement on Monday.
The authorisation clears the way for commercial launch across all EU member states as well as Iceland, Liechtenstein and Norway.
In May 2024, Dr Reddy’s and Alvotech had entered into a license and supply agreement for the commercialisation of AVT03. Under the agreement, Alvotech will develop and manufacture AVT03, while Dr Reddy’s is responsible for registration and commercialisation in applicable markets, including the US and Europe. Dr. Reddy’s commercialisation rights are exclusive for the US, and semi-exclusive for Europe and the UK.
Upon approval the biosimilar from Dr Reddy’s will be available as Acvybra (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy (denosumab) 70 mg/mL solution for injection in a vial.
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 and bone loss linked to hormone ablation in men with prostate cancer.
Xgeva is a prescription medicine used to prevent bone complications in adults with advanced cancer involving bone.
