The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending AVT03, a biosimilar to Prolia (denosumab) and Xgeva (denosumab), for marketing authorisation.
As part of the regulatory pathway, this CHMP recommendation will now be reviewed by the European Commission (EC). The EC’s decision will determine whether marketing authorisation is granted across the European Economic Area (EEA), which covers all EU member states as well as Norway, Iceland, and Liechtenstein.
A separate Marketing Authorisation Application (MAA) is also planned for submission to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP) via the reliance route.
Prolia: Used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, bone loss linked to hormone ablation in prostate cancer patients, and glucocorticoid-induced bone loss.
Xgeva: Indicated to prevent bone complications in adults with advanced cancer involving bone, and for treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
In May 2024, Dr. Reddy’s Laboratories and Alvotech signed a license and supply agreement for the commercialisation of AVT03. Under this partnership:
Alvotech will develop and manufacture AVT03.
Dr. Reddy’s will handle registration and commercialisation in designated markets, including the U.S. and Europe.
Dr. Reddy’s holds exclusive rights in the U.S. and semi-exclusive rights in Europe and the UK. Once approved, the biosimilar will be marketed under the trade names:
Acvybra (denosumab) solution for injection in a pre-filled syringe
Xbonzy (denosumab) solution for injection in a vial