FDA Grants Interchangeable Designation to Fresenius Kabi’s Biosimilars Conexxence® and Bomyntra® (denosumab-bnht)

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LAKE ZURICH, Ill.--(BUSINESS WIRE)--Oct 29, 2025--

Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the U.S. Food and Drug Administration (FDA) designated Conexxence ®(1) and Bomyntra ®(2) (denosumab-bnht) as interchangeable biosimilars to the reference products, Prolia ®(3) (denosumab) and Xgeva ®(4) (denosumab), respectively.

“Fresenius Kabi is pleased to receive this interchangeable designation for Conexxence and Bomyntra to create access for patients and healthcare professionals to important, high-quality therapies at a reduced cost,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board.

About Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht)

Conexxence ® (denosumab-bnht) is approved for use in various adult patient populations at high risk for fractures, including individuals with osteoporosis, patients undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. In the U.S., Conexxence ® carries a boxed warning and includes a Risk Evaluation and Mitigation Strategy (REMS) program, which aims to educate prescribers and patients about the risk of severe hypocalcemia in patients with advanced chronic kidney disease, including those on dialysis. Conexxence ® is contraindicated in patients with hypocalcemia, during pregnancy and in cases of known hypersensitivity to denosumab products.

Bomyntra ® (denosumab-bnht) is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also indicated for the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy and the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Bomyntra ® (denosumab-bnht) is contraindicated in patients with hypocalcemia and those with known hypersensitivity to denosumab products.

Patients receiving Conexxence ® or Bomyntra ® should not receive other denosumab products concomitantly. If a clinically significant allergic reaction occurs with Conexxence ® or Bomyntra ®, treatment should be permanently discontinued.

For Conexxence ® full Prescribing Information, including boxed warning, please visit https://biosimilars.fresenius-kabi.com/portfolio/products/conexxence. For details on the Conexxence ® REMS program, visit: https://www.conexxencerems.com /

For Bomyntra ® full Prescribing Information, please visit https://biosimilars.fresenius-kabi.com/portfolio/products/bomyntra/dosing-administration.

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.

Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.

(1)(2) Conexxence ® and Bomyntra ® are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.

(3)(4) Prolia ® and Xgeva ® are registered trademarks of Amgen Inc.

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KEYWORD: ILLINOIS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL ONCOLOGY

SOURCE: Fresenius Kabi

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PUB: 10/29/2025 03:56 PM/DISC: 10/29/2025 03:56 PM

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