Dr. Reddy’s Laboratories and Alvotech have announced that the U.S. Food and Drug Administration (FDA) has accepted their 351(k) Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab).
The milestone marks a significant step in bringing a cost-effective alternative for osteoporosis and bone disease treatment to the U.S. market.
Milan Kalawadia, CEO of Dr. Reddy’s North America, highlighted the importance of this acceptance in expanding patient access to biosimilar medicines. Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the potential of AVT03 in addressing the needs of osteoporosis patients and those suffering from bone metastases.
Prolia® is widely used to treat osteoporosis in postmenopausal women at high risk of fractures, while Xgeva® is prescribed to prevent skeletal complications in cancer patients with bone metastases.
Dr. Reddy’s and Alvotech entered into a License and Supply Agreement for AVT03 in May 2024. Under the agreement, Alvotech will handle the development and manufacturing of AVT03, while Dr. Reddy’s will oversee registration and commercialization in key markets, including the U.S.
Following FDA approval, AVT03 will be available in a single-dose prefilled syringe (60 mg/1 mL) and a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.
