FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review

Core Viewpoint - Dr. Reddy's Laboratories and Alvotech announced the FDA's acceptance of a regulatory filing for AVT03, a proposed biosimilar of Amgen's Prolia and Xgeva, which could enhance patient access to affordable treatments for osteoporosis and other bone-related conditions [1][4][6]. Group 1: Product and Market Impact - Prolia generated $2.89 billion in sales in 2024, reflecting an 8$1.51 billion, marking a 5% growth compared to 2023 [3]. - The introduction of AVT03 could improve treatment accessibility for millions affected by osteoporosis in the United States [6]. Group 2: Partnership and Development - Dr. Reddy's and Alvotech signed a license and supply agreement for AVT03 in 2024, with Alvotech responsible for development and manufacturing, while Dr. Reddy's handles registration and commercialization in key markets [7]. - AVT03 is expected to be available in two formulations: a single-dose prefilled syringe containing 60 mg and a single-dose vial with 120 mg [8]. Group 3: Stock Performance - Year to date, Dr. Reddy's shares have lost 15.5%, while Alvotech shares have decreased by 14.3% [3][7]. - Both companies currently carry a Zacks Rank 3 (Hold) [9].