Amneal Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned company, have announced that the US FDA has approved their Biologics Licensing Applications (BLAs) for Boncresa (denosumab-mobz), a biosimilar to Prolia, and Oziltus (denosumab-mobz), a biosimilar to XGEVA.

 

Denosumab, a widely used monoclonal antibody, inhibits bone resorption and is prescribed for oncology and osteoporosis-related conditions. Under the Amneal-mAbxience partnership, mAbxience handles development and manufacturing, while Amneal holds exclusive commercialization rights in the U.S.

 

“Biosimilars are the next wave of affordable medicines in the US, 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 must be administered by a healthcare provider, with patients advised to monitor serum calcium levels and seek medical attention for allergic reactions.

 

Prolia carries a boxed warning for severe hypocalcemia, particularly in patients with advanced chronic kidney disease, and must not be used in pregnancy. Common side effects include back and joint pain, musculoskeletal issues, hypercholesterolemia, and cystitis. 

 

XGEVA’s serious adverse reactions include dyspnea, fatigue, nausea, and hypophosphatemia, with additional risks for patients with bone metastases, multiple myeloma, or giant cell tumors. Both drugs can cause fetal harm.