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 is available in a 60 mg/mL single-use prefilled syringe. Bomyntra is available in a 120 mg/1.7 mL vial and a 120 mg/1.7 mL single-use prefilled syringe.
“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® (denosumab-bnht) and Bomyntra® (denosumab-bnht)
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. In the U.S., Conexxence 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® (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 (denosumab-bnht) is contraindicated in patients with hypocalcemia and those with known hypersensitivity to denosumab products.
For more information, please visit www.fresenius-kabi.com.
