Amneal Pharma-mAbxience gets USFDA approval for Boncresa, Oziltus
Bridgewater: Amneal Pharma and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa (denosumab-mobz), a biosimilar referencing Prolia, and Oziltus (denosumab-mobz), a biosimilar referencing XGEVA.
Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related conditions. Under Amneal’s partnership with mAbxience, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive U.S. commercialization rights.
“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,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.
“The FDA approval of our denosumab biosimilars marks a significant milestone for mAbxience and for our collaboration with Amneal. It reflects the strength of our scientific capabilities, our commitment to the highest quality standards, and our shared ambition to expand access to affordable, high-quality biologic medicines in the United States. This achievement reinforces our globalization strategy and our purpose of helping address unmet patient needs through innovation and reliable manufacturing,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience.
Both drugs should 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. Pregnancy must be ruled out prior to administration. In postmenopausal women, reported adverse drug events included back pain, musculoskeletal pain, hypercholesterolemia, and cystitis. Back pain, joint pain, and nasopharyngitis were frequently reported by men.
According to IQVIA, U.S. annual sales for Prolia and XGEVA for the 12 months ended October 2025 were approximately $5.3 billion.
