Fresenius Expands Biosimilars Portfolio With the Availability of Their Denosumab Biosimilars in the U.S.
Fresenius announced today that its operating company Fresenius Kabi, has introduced two new biosimilars - Conexxence®(1) (denosumab-bnht) and Bomyntra®(2) (denosumab-bnht) - in the United States.
These denosumab biosimilars are approved by the FDA for all indications of the reference products, Prolia®(3) (denosumab) and Xgeva®(4) (denosumab), respectively.
“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®(1) (denosumab-bnht) and Bomyntra®(2) (denosumab-bnht)
Conexxence®(1) (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®(1) 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.
Bomyntra®(2) (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®(2) (denosumab-bnht) is contraindicated in patients with hypocalcemia and those with known hypersensitivity to denosumab products.
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 critically and chronically ill patients. With more than 41,000 employees and present in over 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 the 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. 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.
(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.
