mAbxience and Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®

MADRID, Dec. 22, 2025 /PRNewswire/ -- mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ: AMRX), 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.

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.

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