Alvotech and Dr. Reddy's enter into collaboration for commercialization of AVT03 (denosumab), a biosimilar candidate to Prolia® & Xgeva® in the U.S., Europe and UK

Core Insights - Dr. Reddy's Laboratories has secured exclusive commercialization rights for AVT03, a biosimilar candidate to Prolia® and Xgeva®, in the U.S. and semi-exclusive rights in Europe and the UK [1][2] - Alvotech will handle the development and manufacturing of AVT03, while Dr. Reddy's will manage registration and commercialization in the relevant markets [2][3] - The agreement includes an upfront payment to Alvotech, with additional payments tied to regulatory and commercialization milestones, as well as sales-based payments [2] Company Overview - Dr. Reddy's Laboratories is a global pharmaceutical company based in Hyderabad, India, focusing on providing affordable and innovative medicines across various therapeutic areas [7][8] - The company has developed a portfolio of biosimilar products and aims to expand its offerings in highly regulated markets [3][8] - Alvotech is a biotech company dedicated to developing and manufacturing biosimilar medicines, with a current pipeline of eight biosimilar candidates targeting various diseases [12] Product Information - AVT03 is a human monoclonal antibody biosimilar candidate to denosumab, indicated for treating osteoporosis and preventing skeletal-related events in patients with advanced malignancies [4] - Positive top-line results from a pharmacokinetic study of AVT03 compared to Prolia® were announced in January 2024, with ongoing studies to confirm efficacy and safety [4] Strategic Collaboration - The partnership between Dr. Reddy's and Alvotech aims to enhance the availability of cost-effective biologic medications globally, emphasizing the importance of biosimilars in healthcare systems [3][12] - Both companies share a commitment to improving patient access to safe and effective biologics, leveraging their combined resources for better service delivery [3][12]