Alvotech and Dr. Reddy's Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®

Core Insights - The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar of Prolia® and Xgeva® developed by Alvotech, in collaboration with Dr. Reddy's Laboratories [1][2][5] Company Overview - Dr. Reddy's Laboratories is a global pharmaceutical company based in Hyderabad, India, established in 1984, focusing on providing access to affordable and innovative medicines across various therapeutic areas [8] - Alvotech is a biotech company specializing in the development and manufacture of biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates [12] Product Details - AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations, targeting osteoporosis and skeletal-related events in patients with advanced malignancies [6][4] - The product is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution and a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial after FDA approval [5] Strategic Partnership - In May 2024, Dr. Reddy's and Alvotech entered into a License and Supply Agreement for AVT03, where Alvotech is responsible for development and manufacturing, while Dr. Reddy's handles registration and commercialization in applicable markets, including the U.S. [5]