Dr. Reddy’s Laboratories has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation for AVT03, a biosimilar of Prolia (Denosumab) and Xgeva (Denosumab) in European markets.

As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Economic Area (EEA), which includes the European Union (EU) member countries, in addition to Norway, Iceland and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP).

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, bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term treatment with systemic glucocorticoid.

Xgeva is a prescription medicine used to prevent bone complications in adults with advanced cancer involving bone, and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.

In May 2024, Dr. Reddy’s and Alvotech entered into a licence 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, Dr. Reddy’s will offer the biosimilar under the tradenames 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.

AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia and Xgeva, which are both denosumab but in different presentations. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.