Dr. Reddy’s Laboratories has announced that the European Commission (EC) has granted marketing authorization for AVT03, a biosimilar of Amgen’s flagship denosumab brands Prolia and Xgeva. Prolia is indicated for the treatment of osteoporosis, while Xgeva is used to prevent bone complications in adults with advanced cancer.

Dr. Reddy’s holds exclusive commercial rights for AVT03 in the US and semi-exclusive rights in Europe, following its in-licensing agreement with Alvotech. The biosimilar will be marketed under the brand names Acvybra (Prolia biosimilar) and Xbonzy (Xgeva biosimilar) in approved territories.

The approval marks a significant milestone for Dr. Reddy’s in expanding its biosimilar portfolio in Europe. Several other Indian pharmaceutical companies, including Biocon Biologics, are also working on denosumab biosimilars. Biocon Biologics received US FDA approval in September for its brands Bosaya and Aukelso.

The launch of AVT03 will help broaden access to critical therapies for osteoporosis and cancer-related bone diseases across Europe, reinforcing the capabilities of Indian biopharma firms in the global biosimilars market.