Amneal Pharmaceuticals, Inc. (AMRX) announced late Monday that the U.S. Food and Drug Administration has approved the Biologics Licensing Applications or BLAs for Boncresa (denosumab-mobz), a biosimilar referencing Prolia, and Oziltus (denosumab-mobz), a biosimilar referencing XGEVA. The company added that it expects to commercialize six biosimilars across eight presentations by 2027.
Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related conditions.
Under a partnership deal, Spain-based mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, is responsible for development and manufacturing of Denosumab, while Amneal holds exclusive U.S. commercialization rights.
According to IQVIA, U.S. annual sales for Amgen Inc.'s Prolia and XGEVA for the 12 months ended October 2025 were approximately $5.3 billion.
Under the approval, both drugs are required to be administered by a healthcare provider. Patients should be advised to maintain serum calcium levels and to seek medical attention for an allergic reaction.
Prolia has a Boxed Warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. For XGEVA, the most serious reported adverse drug reaction was dyspnea, with other reactions including fatigue, nausea, and hypophosphatemia.
Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, said, "Biosimilars are the next wave of affordable medicines in the U.S., expanding access to life-changing biologics for millions of patients. With the addition of two denosumab biosimilars, Amneal now has five commercial biosimilars, strengthening our position in this rapidly growing category. We view biosimilars as a major long-term growth vector within our Affordable Medicines segment."
On the Nasdaq, Amneal Pharma shares closed Monday's regular trading 2% higher at $12.82. In the after-hours, the shares gained 0.9% further to trade at $12.93.
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