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Amneal Reports FDA Approval of Denosumab Biosimilars
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Amneal Reports FDA Approval of Denosumab Biosimilars
Mar 10, 2026 11:12 PM

04:35 PM EST, 12/22/2025 (MT Newswires) -- Amneal Pharmaceuticals ( AMRX ) and partner mAbxience said late Monday that the US Food and Drug Administration has approved their denosumab biosimilars, Boncresa and Oziltus.

Boncresa is a biosimilar referencing Prolia, and Oziltus is a biosimilar referencing XGEVA, they said.

Under the partnership, mAbxience develops and manufactures the drugs, while Amneal holds exclusive US commercialization rights, according to the report. Amneal expects to commercialize six biosimilars across eight presentations by 2027.

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