FDA accepts BLA submission from Dr. Reddy's, Alvotech for proposed Prolia, Xgeva biosimilars

Dr. Reddy’s and Alvotech shared that the Food and Drug Administration has accepted a 351(k) Biologic License Application submission for AVT03, which was developed by Alvotech, and is a proposed biosimilar of Prolia (denosumab) and Xgeva (denosumab).

“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, CEO 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.

[Related: Alvotech, Dr. Reddy’s collaborate for biosimilar candidate to Prolia, Xgeva]

Prolia is 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 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 AVT03. Under the agreement, Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy’s is responsible for registration and commercialization in applicable markets, including the United States. After approval by the FDA, AVT03 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.

[Read more: Dr. Reddy’s debuts on Dow Jones Sustainability World Index]