mAbxience And Amneal Announce FDA Approval For Denosumab Biosimilars, Referencing Prolia® And XGEVA®

Madrid /PRNewswire/ - mAbxience, a group of companies majority-owned by Fresenius Kabi and partly owned by Insud Pharma, and Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) announced today that the U.S. Food and Drug Administration (FDA) has approved their Biologics License Applications (BLAs) for Boncresa™ (denosumab mobz), a biosimilar based on Prolia®, and Oziltus™ (denosumab mobz), a biosimilar based on XGEVA®.

Denosumab is a monoclonal antibody that inhibits bone resorption and is frequently used in oncology and osteoporosis treatment. Under the partnership between Amneal and mAbxience, mAbxience is responsible for development and manufacturing, while Amneal holds the exclusive marketing rights in the US.

“Biosimilars represent 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 new denosumab biosimilars, Amneal now has five commercially available biosimilars, strengthening its position in this rapidly growing category. We view biosimilars as an important long-term growth driver within our Affordable Medicines segment , ” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.

“The FDA approval of our denosumab biosimilars is 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 goal of expanding access to affordable, high-quality biologic medicines in the United States. This success reinforces our globalization strategy and our goal of helping to address unmet patient needs through innovation and reliable manufacturing , ” said Jürgen Van Broeck, Chief Executive Officer of mAbxience.

Both medications should be administered by a doctor. Patients should be advised to maintain their serum calcium levels and to consult a doctor if allergic reactions occur.

Prolia®: Prolia carries a warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. Pregnancy must be ruled out before administration. Adverse drug reactions reported in postmenopausal women include back pain, musculoskeletal pain, hypercholesterolemia, and cystitis. Back pain, joint pain, and nasopharyngitis have been frequently reported by men.

XGEVA®: The most serious reported adverse reaction was dyspnea; other adverse reactions included fatigue, nausea, and hypophosphatemia. Fatigue and nausea were common adverse reactions in patients treated for bone metastases, while gastrointestinal problems and anemia were common in patients with multiple myeloma. Pain, nausea, and headache were common in cases of giant cell tumors and malignant hypercalcemia. Treatment was discontinued in some patients due to osteonecrosis or hypocalcemia. The drug may harm the fetus; therefore, women of childbearing 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, New Jersey, is a global biopharmaceutical company. We make health possible by developing, manufacturing, and distributing a diverse portfolio of more than 290 medicines, primarily in the United States. In the Affordable Medicines segment, the company is expanding across a variety of complex product categories and therapeutic areas, including injectables and biosimilars. In the Specialty segment, Amneal has a growing portfolio of branded medicines focused primarily on central nervous system and endocrine disorders. Through its AvKARE division, the company distributes medicines and other products to 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 company specializing in the development, manufacturing, 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 in mAbxience, transforming it into a global, vertically integrated biotechnology company. With over a decade of experience, mAbxience has a clear mission: to provide globally accessible, affordable medicines to improve quality of life through universal access to high-quality medications. With three approved products and a robust pipeline in development, mAbxience has established a B2B presence in over 100 markets. Furthermore, the company has built a network of more than 30 partners and a dedicated team of over 1,000 professionals. Its three multi-product sites in Europe and South America have received GMP approval from renowned regulatory authorities such as the FDA, EMA, and others. Furthermore, mAbxience, as a global biopharmaceutical expert, specializes in contract development and manufacturing organization (CDMO) services, leveraging advanced technologies and innovative platforms to offer integrated manufacturing solutions. For more information about mAbxience, our biosimilars, and our CDMO business, please visit our website ( www.mabxience.com ) or connect with us on LinkedIn .

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