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Fresenius Announces U.S. FDA Acceptance for Review of Biologics License Application for Denosumab Biosimilar Candidate

May 27, 2024

Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for FKS518, its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab). 

“Today’s BLA submission acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biosimilar products. Our goal is to continue to grow and expand our biosimilars development capabilities and product portfolio and with today’s news, I am pleased that we are closer to providing patients and clinicians in the U.S. with another biosimilar product and access to more affordable therapies,” said Dr. Michael Schönhofen, President Fresenius Kabi Biopharmaceuticals.

FKS518 is being developed as a biosimilar of denosumab by Fresenius Kabi using advanced analytical and manufacturing methods for use in the treatment of postmenopausal osteoporosis in women, glucocorticoid-induced osteoporosis, to increase bone mass in men and women at high risk for fracture, increase bone mass in men with osteoporosis, prevention of skeletal-related events in cancer patients, treatment of adults and skeletally mature adolescents with giant cell tumor of bone and treatment of hypercalcemia.The BLA submission for its denosumab biosimilar candidate is based on comprehensive analytical development and similarity assessment supported by two clinical comparative studies (one pharmacokinetic study and one efficacy and safety study).

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About Fresenius Kabi 

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. 

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. 

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

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

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