---
title: "FDA approves Amneal's biosimilars Boncresa™ and Oziltus™ referencing Prolia® and XGEVA® on Dec. 22, 2025."
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/270534140.md"
description: "Amneal Pharmaceuticals, Inc. in Bridgewater, New Jersey, revealed on December 22, 2025, that the U.S. Food and Drug Administration (FDA) has given the green light to its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz) and Oziltus™ (denosumab-mobz). These biosimilars, which reference Prolia ® and XGEVA ® respectively, are a collaboration between Amneal and mAbxience, a group mainly owned by Fresenius Kabi with some ownership held by Insud Pharma. Amneal Pharmaceuticals trades on the NASDAQ under the ticker symbol AMRX."
datetime: "2025-12-22T21:03:00.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/270534140.md)
  - [en](https://longbridge.com/en/news/270534140.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/270534140.md)
---

> Supported Languages: [简体中文](https://longbridge.com/zh-CN/news/270534140.md) | [繁體中文](https://longbridge.com/zh-HK/news/270534140.md)


# FDA approves Amneal's biosimilars Boncresa™ and Oziltus™ referencing Prolia® and XGEVA® on Dec. 22, 2025.

Amneal Pharmaceuticals, Inc. in Bridgewater, New Jersey, revealed on December 22, 2025, that the U.S. Food and Drug Administration (FDA) has given the green light to its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz) and Oziltus™ (denosumab-mobz). These biosimilars, which reference Prolia ® and XGEVA ® respectively, are a collaboration between Amneal and mAbxience, a group mainly owned by Fresenius Kabi with some ownership held by Insud Pharma. Amneal Pharmaceuticals trades on the NASDAQ under the ticker symbol AMRX.

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