Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced that the U.S. Food and Drug Administration (FDA) designated Conexxence and Bomyntra(denosumab-bnht) as interchangeable biosimilars to the reference products, Prolia (denosumab) and Xgeva.
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“Fresenius Kabi is pleased to receive this interchangeable designation for Conexxence and Bomyntra to create access for patients and healthcare professionals to important, high-quality therapies at a reduced cost,” said Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board.
About Conexxence and Bomyntra
Conexxence 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 boxed 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.
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Bomyntra 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.
Patients receiving Conexxence or Bomyntra should not receive other denosumab products concomitantly. If a clinically significant allergic reaction occurs with Conexxence or Bomyntra, treatment should be permanently discontinued.
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Source- businesswire
