Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement

• Conexxence^® (denosumab-bnht) and Bomyntra^® (denosumab-bnht) received FDA approval for all indications of the reference products: Prolia^® (denosumab) and Xgeva^® (denosumab) respectively.

• Fresenius’ operating company Fresenius Kabi reached a global settlement with Amgen concerning their denosumab biosimilars, allowing launch in the U.S. in mid-2025 and in Europe later in H2 of 2025, subject to regulatory approvals.

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence^® (denosumab-bnht) and Bomyntra^® (denosumab-bnht) of its operating company Fresenius Kabi, has been approved by the U.S. Food and Drug Administration (FDA). These denosumab biosimilars are approved for all indications of the reference products: Prolia^® (denosumab) and Xgeva^® (denosumab), respectively. In addition, the Fresenius operating company has reached a global settlement with Amgen concerning its denosumab biosimilars.

“We are pleased to have reached a global settlement with Amgen for our denosumab biosimilar candidates and to continue to provide patients around the globe with access to high-quality biological medicines. This marks our sixth FDA biosimilar approval, expanding our portfolio to provide more affordable therapies to patients in the U.S.,” said Dr. Sang Jin Pak, President Fresenius Kabi Biopharma.

The FDA approval is based on comprehensive analytical development and similarity assessment supported by two comparative clinical studies: a pharmacokinetic, pharmacodynamic, and immunogenicity study in healthy volunteers, and an efficacy, pharmacodynamic, safety, and immunogenicity study in women with postmenopausal osteoporosis.

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 those with osteoporosis, individuals undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy.

In the US Conexxence^® (denosumab-bnht) is a black box warning product 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^® (denosumab-bnht) is contraindicated during pregnancy and in case of known hypersensitivity to denosumab products.

For more information about Conexxence^® please see the important safety information and full prescribing information for the U.S. here.

Bomyntra^® (denosumab-bnht) is approved for use to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors. It is also used to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy and giant cell tumor of bone in adults and skeletally mature adolescents. Bomyntra^® (denosumab-bnht) is contraindicated in case of hypocalcemia and known hypersensitivity to denosumab products.

For more information about Bomyntra^® please see the important safety information and full prescribing information for the U.S. here.

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 43,000 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 – notably as the only corporation offering both product groups. 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 Vision 2026, as part of 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 health care.

Fresenius Kabi is an operating company 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 health care solutions on a global scale.

For more information, please visit www.fresenius-kabi.com and www.fresenius-kabi.com/us in the United States. 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.

Prolia^® and Xgeva^® are registered trademarks of Amgen Inc.

Conexxence^® and Bomyntra^® are registered trademarks of Fresenius Kabi Deutschland in selected countries.