Fresenius Kabi’s denosumab biosimilar candidate FKS518 shows positive clinical trial results

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.

"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: https://clinicaltrials.gov

For more information about Fresenius Kabi's work in biosimilars, please visit https://biopharma.fresenius-kabi.com