Alvotech and Dr. Reddy's Celebrate FDA Acceptance of AVT03 Biosimilar Application

Alvotech and Dr. Reddy's have announced a significant milestone with the FDA's acceptance of their Biologic License Application (BLA) for AVT03, a proposed biosimilar to Amgen's Prolia and Xgeva. AVT03 is a human monoclonal antibody designed to treat osteoporosis and prevent skeletal-related events in cancer patients. This development marks an important step towards expanding access to affordable biologic medicines for patients in the U.S. Alvotech will handle the development and manufacturing of AVT03, while Dr. Reddy's will oversee registration and commercialization in applicable markets. The partnership aims to leverage Alvotech's biosimilars platform and Dr. Reddy's commercial expertise to bring this critical treatment to more patients.

 

Source: StreetInsider, Biospace