Amneal adds 2 denosumab biosimilars to U.S. pipeline oncology portfolio

Amneal Pharmaceuticals announced the addition of two denosumab biosimilars referencing both Prolia and XGEVA to its biosimilar pipeline. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. The two denosumab products are being developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Under the terms of the agreement, mAbxience will fully develop the biosimilar molecule and manufacture it in its state-of-the-art, Good Manufacturing Practice, GMP approved facilities, while Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience also currently partner on ALYMSYS , a bevacizumab biosimilar. “Our goal is to be a top five player in the U.S. biosimilar space, similar to our leadership position in U.S. retail generics. The financial terms of the transaction were not disclosed, and any incremental expenses associated with these products are contemplated within Amneal’s guidance.