FDA Reviews Dr. Reddy’s & Alvotech’s AVT03, A Biosimilar For Osteoporosis & Bone Metastases

Dr. Reddy’s Laboratories and Alvotech announced that the FDA has accepted their 351(k) Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab). Prolia® is used to treat osteoporosis in postmenopausal women at high risk for fractures, while Xgeva® is prescribed for bone complications in patients with multiple myeloma or bone metastases from solid tumors.

“The FDA's filing acceptance of Dr Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan Kalawadia, Chief Executive Officer of Dr. Reddy’s North America.

“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.

Under their May 2024 agreement, Alvotech handles development and manufacturing, while Dr Reddy’s will manage the regulatory approval and commercialisation, including the U.S. market. If approved, AVT03 will be available in prefilled syringes (60 mg/1 mL) and single-dose vials (120 mg/1.7 mL).