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Fresenius Expands Biosimilars Portfolio With The Launch of Denosumab Biosimilars in the U.S.

via Business Wire
  • Fresenius Kabi’s fifth and sixth biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) have launched in the U.S. for all approved indications for their respective reference products, Prolia® (denosumab) and Xgeva® (denosumab).
  • Expansion of Fresenius Kabi’s Biopharma platform remains central to newest phase of the #FutureFresenius strategy Rejuvenate.
  • U.S. launches of Conexxence® and Bomyntra® follow their FDA approval in March 2025.

Fresenius announced today that its operating company Fresenius Kabi, has introduced two new biosimilars - Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) - in the United States.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701511446/en/

Fresenius Kabi continues the expansion of its biosimilars portfolio in the U.S. with the introduction of Conexxence (denosumab-bnht) and Bomyntra® (denosumab-bnht) in the United States. Bomyntra is available in a 120 mg/1.7 mL vial and a 120 mg/1.7 mL single-use prefilled syringe and is FDA approved for all indications of the reference product Xgeva® (denosumab).

Fresenius Kabi continues the expansion of its biosimilars portfolio in the U.S. with the introduction of Conexxence (denosumab-bnht) and Bomyntra® (denosumab-bnht) in the United States. Bomyntra is available in a 120 mg/1.7 mL vial and a 120 mg/1.7 mL single-use prefilled syringe and is FDA approved for all indications of the reference product Xgeva® (denosumab).

These denosumab biosimilars are approved by the FDA for all indications of the reference products, Prolia® (denosumab) and Xgeva® (denosumab), respectively.

Conexxence is available in a 60 mg/mL single-use prefilled syringe. Bomyntra is available in a 120 mg/1.7 mL vial and a 120 mg/1.7 mL single-use prefilled syringe.

“Fresenius Kabi is very pleased to continue the consistent launches of new biosimilars for U.S. patients, providers and payors,” said Dr. Sang Jin Pak, President Fresenius Kabi Biopharma. “Access to high-quality biological medicines creates the opportunity to provide more affordable therapies to patients and as our biosimilar portfolio expands, we will be able to provide access for even more patients.”

Earlier this year, Fresenius announced Fresenius Kabi reached a global settlement with Amgen concerning its denosumab biosimilars.

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 black box 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.

For more information about Conexxence® please refer to the Important Safety Information and Full Prescribing Information for the U.S. here.

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.

For more information about Bomyntra® please refer to 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 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 biosimilars for autoimmune diseases, oncology and osteoporosis. With leading market positions in Clinical Nutrition, a broad global 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 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 healthcare 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 healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. In line 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 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 healthcare solutions on a global scale.

For more information, please visit www.fresenius-kabi.com. 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.

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

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

“Fresenius Kabi is very pleased to continue the consistent launches of new biosimilars for U.S. patients, providers and payors,” said Dr. Sang Jin Pak, President Fresenius Kabi Biopharma.

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