Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®
Rhea-AI Summary
Amneal (NASDAQ: AMRX) announced FDA approval of two denosumab biosimilars: Boncresa (denosumab-mobz) referencing Prolia and Oziltus (denosumab-mobz) referencing XGEVA, dated Dec 22, 2025.
Under the Amneal–mAbxience partnership, mAbxience handles development and manufacturing while Amneal holds exclusive U.S. commercialization rights. The company expects to commercialize six biosimilars across eight presentations by 2027. IQVIA reports combined U.S. annual sales for Prolia and XGEVA of approximately $5.3 billion for the 12 months ended Oct 2025.
Positive
- FDA approval of two denosumab biosimilars (Prolia and XGEVA references)
- Exclusive U.S. commercialization rights for Amneal under the partnership
- Plan to commercialize 6 biosimilars across 8 presentations by 2027
- Reference market size: $5.3B combined U.S. annual sales (Prolia and XGEVA, 12 months ended Oct 2025)
Negative
- Prolia boxed warning for severe hypocalcemia and pregnancy precautions could limit use
- XGEVA safety warnings include fetal harm and reports of dyspnea, fatigue, nausea
- Reported discontinuations for some patients due to osteonecrosis or hypocalcemia
News Market Reaction
On the day this news was published, AMRX gained 0.16%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
While AMRX was down 0.55%, key peers were mixed: PBH +0.49%, BHC +1.18%, HCM +1.57%, INDV -0.93%, PRGO -0.23%, suggesting today’s FDA approval impact was stock-specific rather than a broad sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 09 | FDA hospital injectable | Positive | +2.0% | FDA approval of epinephrine injection vials for hospital and acute care use. |
| Dec 05 | Clinical data update | Positive | +2.4% | Positive interim Phase 4 ELEVATE-PD results for CREXONT in Parkinson’s disease. |
| Dec 02 | Investor conferences | Neutral | -2.5% | Participation in Piper Sandler and J.P. Morgan healthcare conferences with webcasts. |
| Dec 02 | FDA respiratory approval | Positive | -2.5% | FDA approval of albuterol sulfate inhalation aerosol, a complex respiratory generic. |
| Dec 01 | FDA ophthalmic approval | Positive | -2.5% | FDA approval of cyclosporine ophthalmic emulsion 0.05% as generic RESTASIS. |
FDA approvals have produced mixed reactions, with slightly more divergences (negative moves on positive news) than alignments.
Over the last few months, Amneal has reported multiple U.S. FDA approvals across injectables, respiratory, and ophthalmic products, alongside positive Phase 4 data in Parkinson’s disease. Recent approvals for epinephrine, albuterol, cyclosporine, iohexol, and bimatoprost referenced U.S. annual sales ranging from $118 million to about $2.0 billion. Price reactions around these events were inconsistent, sometimes negative despite positive catalysts. Today’s denosumab biosimilar approvals continue this pattern of expanding the Affordable Medicines and biosimilars portfolio against a backdrop of varied market responses.
Market Pulse Summary
This announcement highlights FDA approval of two denosumab biosimilars that reference Prolia and XGEVA, products with U.S. annual sales of $5.3 billion. It further extends Amneal’s biosimilars footprint, with expectations to commercialize six biosimilars across eight presentations by 2027. Historically, multiple FDA approvals have steadily broadened the portfolio, though financial filings show mixed earnings trends and substantial long-term debt of $2.57 billion, which remain key factors to monitor.
Key Terms
biosimilars medical
biologics licensing applications regulatory
monoclonal antibody medical
boxed warning regulatory
hypocalcemia medical
osteonecrosis medical
AI-generated analysis. Not financial advice.
- 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
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
What did Amneal (AMRX) announce on December 22, 2025 regarding denosumab biosimilars?
How will Amneal commercialize the approved denosumab biosimilars in the U.S. (AMRX)?
What is Amneal's commercialization plan for biosimilars through 2027 (AMRX)?
How large is the U.S. market for the referenced Prolia and XGEVA drugs?
What safety warnings for Prolia and XGEVA were highlighted that may affect prescribing decisions?
