Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®
MWN-AI** Summary
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) has announced the FDA approval of two new denosumab biosimilars, Boncresa™ (referencing Prolia®) and Oziltus™ (referencing XGEVA®). This approval, achieved through a collaboration with mAbxience, enhances Amneal’s growing biosimilars portfolio, which now includes five commercial biosimilars. The companies intend to leverage this approval to expand access to affordable biologic medicines in the U.S., a market where annual sales for Prolia® and XGEVA® reached approximately $5.3 billion as of October 2025, according to IQVIA®.
Denosumab is a pivotal monoclonal antibody that addresses issues related to bone resorption, making it valuable in oncology and osteoporosis treatments. Under the partnership, while mAbxience oversees the development and manufacturing of these biosimilars, Amneal retains exclusive rights to commercialize them in the United States.
Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, emphasized the importance of biosimilars in increasing patient access to critical therapies. The company has outlined plans to commercialize six biosimilars across eight presentations by 2027, positioning biosimilars as key drivers of long-term growth within Amneal’s Affordable Medicines segment.
The approval is also a significant victory for mAbxience, underscoring the company’s scientific capabilities and commitment to quality and innovation. Both biosimilars will be administered by healthcare providers, and patients should be made aware of potential side effects, which include severe hypocalcemia for Prolia® and dyspnea for XGEVA®.
As Amneal continues to expand its footprint in the biosimilars market, it aims to meet the growing demand for affordable healthcare solutions while effectively tackling unmet medical needs.
MWN-AI** Analysis
Amneal Pharmaceuticals' recent FDA approval of denosumab biosimilars Boncresa™ and Oziltus™ marks a pivotal development in its growth trajectory, especially within its Affordable Medicines segment. With this approval, Amneal expands its biosimilars portfolio to five products, positioning itself strategically in a rapidly evolving market predicted to enhance patient access to cost-effective biologic therapies.
The denosumab biosimilars, referencing Prolia® and XGEVA®, are particularly significant due to the substantial market share of their reference products, which collectively had U.S. annual sales exceeding $5.3 billion as of October 2025. The ability to offer comparable alternatives will likely facilitate competitive pricing strategies and could capture a notable portion of the market, potentially driving revenue growth for Amneal.
Investors should take note of Amneal's ambition to commercialize six biosimilars across eight presentations by 2027. This proactive approach indicates a robust pipeline that leverages existing demand for biosimilars, driven by the increasing focus on reducing healthcare costs in the U.S. Furthermore, the collaboration with mAbxience enhances Amneal's capabilities in manufacturing and development, ensuring a steady supply of high-quality products that adhere to stringent FDA guidelines.
However, there are inherent risks associated with biosimilar approval and market penetration, including potential market volatility and competition from other pharmaceutical companies. It will be crucial for Amneal to execute effective marketing strategies and educate healthcare providers on the therapeutic equivalence and benefits of its biosimilars.
In summary, Amneal Pharmaceuticals is positioned well for growth within the biosimilars market, and investors may consider this as a promising long-term investment opportunity. Continuous monitoring of sales performance and market dynamics will be essential as the company navigates this competitive landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Approvals expand Amneal’s biosimilars portfolio
- Company expects to commercialize six biosimilars across eight presentations by 2027
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®, and Oziltus™ (denosumab-mobz), a biosimilar referencing XGEVA®.
Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related conditions. Under Amneal’s partnership with mAbxience, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive U.S. commercialization rights.
“Biosimilars are the next wave of affordable medicines in the U.S., expanding access to life-changing biologics for millions of patients. With the addition of two denosumab biosimilars, Amneal now has five commercial biosimilars, strengthening our position in this rapidly growing category. We view biosimilars as a major long-term growth vector within our Affordable Medicines segment,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.
“The FDA approval of our denosumab biosimilars marks a significant milestone for mAbxience and for our collaboration with Amneal. It reflects the strength of our scientific capabilities, our commitment to the highest quality standards, and our shared ambition to expand access to affordable, high-quality biologic medicines in the United States. This achievement reinforces our globalization strategy and our purpose of helping address unmet patient needs through innovation and reliable manufacturing,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience.
Both drugs should be administered by a healthcare provider. Patients should be advised to maintain serum calcium levels and to seek medical attention for an allergic reaction.
Prolia®: Prolia has a Boxed Warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. Pregnancy must be ruled out prior to administration. In postmenopausal women, reported adverse drug events included back pain, musculoskeletal pain, hypercholesterolemia, and cystitis. Back pain, joint pain, and nasopharyngitis were frequently reported by men.
XGEVA®: The most serious reported adverse drug reaction was dyspnea, with other reactions including fatigue, nausea, and hypophosphatemia. For patients been treated for bone metastases, common side effects were fatigue and nausea, while those with multiple myeloma frequently experienced gastrointestinal issues and anemia. Cases of giant cell tumor and hypercalcemia of malignancy showed frequent pain, nausea, and headache. Discontinuation occurred in some patients due to osteonecrosis or hypocalcemia. The drug can cause fetal harm and females of reproductive potential should use effective contraception.
According to IQVIA®, U.S. annual sales for Prolia® and XGEVA® for the 12 months ended October 2025 were approximately $5.3 billion.
Note: Prolia® and XGEVA® are registered trademarks of Amgen Inc.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.
About mAbxience
mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, mAbxience’s mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With three approved products and a robust pipeline in development, mAbxience has established a B2B presence in over 100 markets. Alongside this, the company has formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Its three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website (www.mabxience.com) or connect with us on LinkedIn.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Amneal Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
mAbxience Contact
Miguel Martínez-Cava
Corporate Affairs & Marketing Associate Director
miguel.martinezcava@mabxience.com
FAQ**
How does the approval of the denosumab biosimilars strengthen Amneal Pharmaceuticals Inc. Class A AMRX’s position in the competitive biosimilars market and impact their growth strategy?
What measures is Amneal Pharmaceuticals Inc. Class A AMRX taking to ensure the successful commercialization of Boncresa™ and Oziltus™, considering the anticipated sales volume of Prolia® and XGEVA®?
How will Amneal Pharmaceuticals Inc. Class A AMRX manage potential safety concerns and adverse effects associated with the denosumab biosimilars in their marketing strategy?
With the partnership with mAbxience, what future collaborations or innovations can we expect from Amneal Pharmaceuticals Inc. Class A AMRX to expand its biosimilars portfolio beyond the current offerings?
**MWN-AI FAQ is based on asking OpenAI questions about Amneal Pharmaceuticals Inc. Class A (NASDAQ: AMRX).
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