Amneal Pharma Wins FDA Nod for Denosumab Biosimilars

Amneal Pharmaceuticals Inc. got an approval from the FDA for two denosumab biosimilars, growing their biosimilar offerings in the US. These are Boncresa (denosumab-mobz), similar to Amgen’s Prolia, and Oziltus (denosumab-mobz), which is like Xgeva.

Amneal worked with mAbxience, a biopharmaceutical company mainly owned by Fresenius Kabi with some ownership by Insud Pharma, to submit the applications. mAbxience handles making the drugs, and Amneal has the exclusive right to sell them in the US.

Denosumab is a monoclonal antibody that helps prevent bone loss and is often used for cancer and osteoporosis. With Boncresa and Oziltus, Amneal now has five biosimilars on the market, boosting their position in the growing affordable medicines area. The company sees biosimilars as a way to grow its business as the US looks for cheaper biologic drugs.

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mAbxience stated that these approvals show their scientific abilities, manufacturing capacity, and plans to grow globally, as well as their shared aim with Amneal to make high-quality biologic medicines more accessible.

These drugs should only be given by healthcare professionals and come with safety warnings, like the risk of low calcium levels and harm to unborn babies. According to IQVIA, Prolia and Xgeva had about $5.3 billion in combined US sales over the year ending in October 2025, pointing to a big market for denosumab biosimilars.