FDA Accepts BLA for Alvotech and Dr. Reddy's Denosumab Biosimilars

Alvotech and Dr. Reddy’s Laboratories have announced that the U.S. FDA has accepted their Biologics License Application (BLA) for AVT03, a proposed biosimilar to Amgen’s Prolia® and Xgeva®. This biosimilar targets osteoporosis in postmenopausal women and bone complications in cancer patients. AVT03 will be available in two formulations: a 60 mg/1 mL prefilled syringe and a 120 mg/1.7 mL vial.

This milestone marks a significant step toward expanding access to affordable biologics, supporting patients in need of advanced bone health treatments. The FDA's acceptance initiates the formal review process, with approval expected to strengthen Dr. Reddy's position in the global biosimilars market.

Source: GlobeNewswire, Big Molecule Watch, Alvotech Investors News