Fresenius Kabi’s Denosumab Biosimilar Candidate FKS518 Shows Positive Clinical Trial Results

July 12, 2023

Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that its denosumab biosimilar candidate FKS518 successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity. 

The randomized, double-blind, parallel-group study compared the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of FKS518 to the US reference product Prolia®* following a single subcutaneous injection in healthy male subjects. The study met all primary and secondary objectives and successfully demonstrated pharmacokinetic equivalence of FKS518 to the US reference product Prolia®. The pharmacodynamic responses evaluated by quantification of bone turnover biomarkers, as well as safety and immunogenicity data support biosimilarity of FKS518 to the US reference product.

Hand with glove in the laboratory and office of Fresenius Kabi

“At Fresenius Kabi Biopharma, we strive to enable people to live their life beyond their disease. We are delighted with the development progress of our multiple biosimilar candidates in our autoimmune diseases and oncology pipeline. This is another testimonial of our efforts to expand our biosimilar portfolio to provide affordable alternative solutions for patients and healthcare providers around the world while contributing to the sustainability of healthcare systems,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma. 

The company is also conducting a global clinical study with the aim to compare the efficacy, safety, tolerability, and immunogenicity of its denosumab biosimilar candidate FKS518 with the US reference product in postmenopausal women with osteoporosis. 

Further study details can be found on:

*Prolia® is a registered trademark of Amgen Inc. 

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.

With its corporate mission of "caring for life", 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 “Vision 2026”, 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.

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This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.
Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, John Ducker, Andreas Duenkel, Dr. Christian Hauer, Dr. Michael Schönhofen
Chairman of the Supervisory Board: Michael Sen
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654