FDA accepts a 351(k) BLA submission for AVT 03 a proposed biosimilar of Prolia (denosumab) and Xgeva (denosumab).- Alvotech + Dr Reddy's

“This milestone marks an important step in our mission to improve patient lives by expanding access to affordable and quality biologic medicines. We look forward to being able to serve the large population of patients requiring treatment for osteoporosis and other diseases of the bone,” said Joseph McClellan, Chief Scientific Officer for Alvotech.

Prolia is a prescription biologic medicine used to treat osteoporosis in women after menopause who are at high risk for bone fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well . Xgeva is a prescription biologic medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.

In May 2024, Dr. Reddy’s and Alvotech entered into a License and Supply Agreement for AVT 03. Under the agreement, Alvotech is responsible for the development and manufacturing of AVT 03, while Dr. Reddy’s is responsible for registration and commercialization in applicable markets, including the U.S. After approval by the FDA, AVT 03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.

The patents on Prolia/Xgeva  expired in the US on 19 February 2025 and  expired in Europe on 25 June 2022, except for France, Italy, Spain and the UK, where they will expire in 2025