Alvotech and Dr. Reddy’s Announce FDA Acceptance of BLA for AVT03, a Biosimilar for Osteoporosis and Bone Disease
Wednesday, March 19, 2025
Dr. Reddy’s Laboratories and Alvotech have announced that the US Food and Drug Administration (FDA) has accepted the Biologic Licence Application (BLA) for AVT03, a proposed biosimilar to Prolia (denosumab) and Xgeva (denosumab).
AVT03 is a human monoclonal antibody designed as a biosimilar candidate to Prolia and Xgeva. It is currently an investigational product that has not received regulatory approval in any country. Its biosimilarity to the reference medicines has yet to be established by regulatory authorities.
Prolia is a biologic medicine prescribed for postmenopausal women with osteoporosis who are at high risk of fractures or cannot use other osteoporosis treatments. Xgeva is used to prevent skeletal complications such as fractures and spinal cord compression in patients with multiple myeloma or bone metastases from solid tumours.
The application was submitted under the 351(k) pathway, which is used for biosimilar approvals in the United States.
AVT03 has been developed by Alvotech, a global biotechnology company focused on biosimilar medicines, while Dr. Reddy’s is responsible for its registration and commercialisation in key markets, including the US.
The proposed biosimilar aims to expand treatment options for patients with osteoporosis and other bone-related conditions.
Dr. Reddy’s and Alvotech signed a Licence and Supply Agreement for AVT03 in May 2024.
Subject to FDA approval, AVT03 is expected to be available in a single-dose prefilled syringe (60 mg in a 1 mL solution) and a single-dose vial (120 mg/1.7 mL solution, at 70 mg/mL concentration).
Under this partnership, Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy’s will oversee regulatory submissions and marketing.
Source: globenewswire.com
