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

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

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.

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 to treat 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.

“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.”