Amneal Pharmaceuticals and mAbxience, a majority-owned subsidiary of Fresenius Kabi with partial ownership from Insud Pharma, have received U.S. Food and Drug Administration (USFDA) approval for two denosumab biosimilars: Boncresa (denosumab-mobz) and Oziltus (denosumab-mobz).

Boncresa is approved as a biosimilar referencing Prolia, while Oziltus references XGEVA. Both products target conditions involving excessive bone resorption and are used across oncology and osteoporosis-related indications.

Partnership Model and Commercial Strategy

Under the collaboration, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive commercialisation rights in the United States. The approvals expand Amneal’s biosimilars portfolio to five commercially available biosimilars, reinforcing its long-term focus on affordable biologic medicines.

Amneal’s leadership highlighted biosimilars as a strategic growth pillar within its Affordable Medicines segment, citing their role in improving patient access to complex biologic therapies in the U.S. market.

Strengthening Global Biosimilars Capabilities

For mAbxience, the FDA approvals underscore the company’s scientific and manufacturing capabilities, as well as its broader globalisation strategy. The milestone reflects a continued commitment to delivering high-quality biologics that meet stringent regulatory standards while addressing unmet patient needs.

Clinical and Safety Considerations

Both Boncresa and Oziltus are to be administered by healthcare professionals. Patients are advised to maintain appropriate serum calcium levels and seek immediate medical attention in case of allergic reactions.

The reference product Prolia carries a Boxed Warning for severe hypocalcaemia in patients with advanced chronic kidney disease, a risk that can be life-threatening. Pregnancy should be ruled out prior to treatment initiation. Reported adverse events in postmenopausal women include back pain, musculoskeletal pain, hypercholesterolaemia, and cystitis, while commonly reported events in men include back pain, joint pain, and nasopharyngitis.

Market Opportunity

According to IQVIA, combined U.S. annual sales of Prolia and XGEVA for the 12 months ending October 2025 were approximately $5.3 billion, highlighting the significant commercial opportunity for denosumab biosimilars entering the market.

Also read: FDA Clears Oral Version of Wegovy, Expanding Access to GLP-1 Obesity Treatments

Industry Impact

The approvals of Boncresa and Oziltus further intensify competition in the U.S. biosimilars landscape and signal continued momentum in biologics affordability. For manufacturers, payers, and healthcare providers, these developments support broader access to high-cost biologic therapies while reinforcing biosimilars as a key driver of sustainable healthcare systems.

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