Amneal Pharmaceuticals announced that the US 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, the latter is responsible for development and manufacturing, while Amneal holds exclusive US commercialisation rights.

“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, Amneal.

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 (CKD), 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.

 “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 US. This achievement reinforces our globalisation strategy and our purpose of helping address unmet patient needs through innovation and reliable manufacturing,” said Jurgen Van Broeck, Chief Executive Officer, mAbxience.

The most serious reported adverse drug reaction for XGEVA was dyspnea, with other reactions including fatigue, nausea and hypophosphatemia. For patients been treated for bone metastases, common side effects were fatigue and nausea, while those with multiple myeloma frequently experienced gastrointestinal issues and anaemia.

Cases of giant cell tumour and hypercalcemia of malignancy showed frequent pain, nausea and headache. Discontinuation occurred in some patients due to osteonecrosis or hypocalcemia. The drug can cause foetal harm and females of reproductive potential should use effective contraception.