1. FDA approves two new biosimilars for Amneal, expanding portfolio. 2. Amneal plans to launch six biosimilars across eight presentations by 2027. 3. U.S. sales for Prolia and XGEVA approached $5.3 billion in 2025. 4. Biosimilars viewed as key long-term growth vector for Amneal. 5. Partnership with mAbxience strengthens Amneal's commercialization capabilities.
FAQ
Why Bullish?
The FDA approval indicates strong market potential, akin to previous biosimilar introductions which boosted similar companies’ stock prices. Historical precedents show increased investor confidence and stock price appreciation following successful drug approvals, particularly in therapeutic areas experiencing high sales volume.
How important is it?
The article outlines significant FDA approvals and future expectations; hence, it's highly relevant to AMRX's stock trajectory. The strategic partnership and expanded biosimilar offerings substantially position AMRX to capitalize on market opportunities.
Why Long Term?
The impact of successful biosimilar commercialization will unfold over several years, with full market penetration expected by 2027. Similar approvals have historically led to sustained revenue and market share growth over time, establishing long-term viability.
Amneal Pharmaceuticals Gains FDA Approval for Denosumab Biosimilars
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) has announced the U.S. Food and Drug Administration (FDA) approvals for two of its denosumab biosimilars: Boncresa™ (denosumab-mobz), referencing Prolia®, and Oziltus™ (denosumab-mobz), referencing XGEVA®. This significant milestone expands Amneal's current biosimilars portfolio, with plans to commercialize a total of six biosimilars by 2027.
Details of the FDA Approvals
Denosumab, a monoclonal antibody, is utilized primarily in the treatment of conditions related to oncology and osteoporosis due to its ability to inhibit bone resorption. Under the partnership with mAbxience—owned by Fresenius Kabi—mAbxience oversees the development and manufacturing of these biosimilars. Meanwhile, Amneal retains exclusive rights for commercialization in the United States.
Biosimilars as a Major Growth Vector
“Biosimilars represent the next wave of affordable medications, increasing access to essential therapeutics for millions of patients in the U.S.,” stated Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. “With the addition of these two denosumab biosimilars, Amneal now has five commercial biosimilars, solidifying our place in this rapidly growing market. We view this sector as a key long-term growth driver in our Affordable Medicines segment.”
Comments from mAbxience
Jurgen Van Broeck, Chief Executive Officer of mAbxience, commented on the approvals, stating, “The FDA’s approval of our denosumab biosimilars is a significant milestone for both mAbxience and our partnership with Amneal. It underscores the robustness of our scientific capabilities and commitment to providing high-quality, accessible biological therapies.”
Safety and Administration Information
Both Boncresa™ and Oziltus™ should be administered by healthcare professionals, with recommendations for patients to monitor serum calcium levels. Patients may also need to seek immediate medical attention for any allergic reactions.
- Prolia®: Its Boxed Warning stresses the risk of severe hypocalcemia in patients with advanced chronic kidney disease.
- XGEVA®: The most serious adverse events reported include dyspnea, with common reactions such as fatigue and nausea.
Market Potential for Denosumab Biosimilars
According to IQVIA®, the annual U.S. sales for Prolia® and XGEVA® reached approximately $5.3 billion for the 12-month period ending in October 2025. These figures highlight the considerable revenue potential for Amneal’s biosimilars.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals, Inc., trading under the stock symbol AMRX, is based in Bridgewater, NJ. The company specializes in developing, manufacturing, and distributing a wide range of pharmaceuticals, with a strong focus on biosimilars and other complex products. Through its evolving portfolio, the company seeks to enhance patient access to high-quality medications across the U.S.
About mAbxience
Based in Spain, mAbxience operates as a biopharmaceutical development and production company specializing in launching accessible medicines. Following a majority acquisition by Fresenius Kabi, the company aims to expand its footprint globally.
Forward-Looking Statements
Statements in this article regarding future operations, expected financial performance, and growth strategies are forward-looking. These statements are subject to risks and uncertainties described in Amneal’s filings with the Securities and Exchange Commission. It is important to recognize these factors when evaluating the company’s future prospects.