FDA Approves Amneal & mAbxience’s Two Denosumab Biosimilars For Prolia® & Oziltus™ For XGEVA®, Marking Major U.S. Launch Under $5.3B Market

Amneal Pharmaceuticals, Inc. and mAbxience, a Fresenius Kabi majority-owned group partly owned by Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved their Biologics License Applications (BLAs) for two denosumab biosimilars. The approved products are Boncresa™ (denosumab-mobz), a biosimilar to Prolia®, and Oziltus™ (denosumab-mobz), a biosimilar to XGEVA®.

Denosumab is a monoclonal antibody used to prevent bone loss by inhibiting bone resorption. It plays an important role in treating conditions related to oncology and osteoporosis. Under the companies’ partnership structure, mAbxience oversees product development and manufacturing, while Amneal retains exclusive rights to commercialize both biosimilars in the United States.

Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, said that biosimilars represent the next major step in making advanced biologic therapies more affordable for U.S. patients. They noted that with these two new denosumab biosimilars, Amneal now has five commercial biosimilars in its portfolio. According to them, biosimilars form a key part of Amneal’s long-term growth strategy within its Affordable Medicines segment.

Jurgen Van Broeck, CEO of mAbxience, described the FDA approvals as an important milestone for both companies. He explained that the decision reflects the strength of mAbxience’s scientific capabilities and its dedication to high-quality manufacturing standards. He added that the achievement supports the company’s global expansion strategy and advances its goal of increasing access to reliable and affordable biologic medicines in the U.S. Both Boncresa and Oziltus must be administered by a qualified healthcare professional. Patients should be advised to maintain appropriate serum calcium levels and seek medical help if they experience symptoms of an allergic reaction.

Prolia carries a Boxed Warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. Pregnancy must be ruled out before treatment begins. Common adverse events in postmenopausal women have included back pain, musculoskeletal pain, hypercholesterolemia, and cystitis. In men, frequently reported side effects have included back pain, joint pain, and nasopharyngitis.

The most serious adverse reaction reported with XGEVA is dyspnea. Other commonly reported reactions include fatigue, nausea, and hypophosphatemia. For patients receiving treatment for bone metastases, fatigue and nausea were among the most frequent side effects. Individuals with multiple myeloma often experienced anemia and gastrointestinal symptoms. In patients treated for giant cell tumor of bone or hypercalcemia of malignancy, pain, nausea, and headache were commonly observed. Some patients discontinued treatment due to osteonecrosis or hypocalcemia. The drug may cause fetal harm, and women of reproductive potential should use effective contraception.

According to IQVIA, combined U.S. annual sales for Prolia and XGEVA for the 12 months ending October 2025 totaled approximately $5.3 billion. Prolia® and XGEVA® are registered trademarks of Amgen Inc.