As reported on PharmaBiz, Amneal Pharmaceuticals, in collaboration with mAbxience, has received U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars: Boncresa (referencing Prolia) and Oziltus (referencing Xgeva). These biologics are indicated for conditions related to bone health, including osteoporosis and oncology-related complications.
Denosumab, a monoclonal antibody that inhibits bone resorption, plays a critical role in managing skeletal disorders. Under the partnership, mAbxience oversees development and manufacturing, while Amneal holds exclusive commercialization rights in the United States.
Amneal’s co-CEOs highlighted biosimilars as a key growth driver for the company’s Affordable Medicines segment, noting that these approvals expand patient access to cost-effective biologics. mAbxience’s CEO emphasized the milestone as part of a broader strategy to deliver high-quality, affordable treatments globally.
Safety Considerations:
- Both products require administration by a healthcare professional.
- Patients should maintain adequate calcium levels and monitor for allergic reactions.
- Prolia carries a boxed warning for severe hypocalcemia in patients with advanced chronic kidney disease and is contraindicated during pregnancy. Common adverse effects include musculoskeletal pain and hypercholesterolemia.
- Xgeva may cause serious reactions such as dyspnea and hypophosphatemia, with risks of osteonecrosis and fetal harm. Effective contraception is advised for women of reproductive potential.
According to IQVIA, combined U.S. sales for Prolia and Xgeva reached approximately $5.3 billion in the 12 months ending October 2025, underscoring the market potential for these biosimilars.
Amneal currently markets five biosimilars and continues to expand its portfolio across complex therapeutic areas. mAbxience, majority-owned by Fresenius Kabi, specializes in biopharmaceutical development and manufacturing.
