The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorisation in the European markets for AVT03, the biosimilar candidate for which Dr. Reddy’s Laboratories had last year entered into a license and supply agreement with Alvotech.
AVT03 is biosimilar of Amgen’s Prolia and Xgeva (both are denosumab in different presentations). The CHMP positive opinion will now be reviewed by the European Commission, following which a decision will be made on the grant of marketing authorisation in the European Economic Area, which includes the European Union 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, Dr. Reddy’s said on Monday.
Dr. Reddy’s and Alvotech had in May 2024 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 U.S. and Europe. Dr. Reddy’s commercialization rights are exclusive for the U.S., and semi-exclusive for Europe and the U.K. 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, the company said.
Prolia is 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. Xgeva is 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, the company said in a release.
Published – September 22, 2025 09:55 pm IST
