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In a landmark decision, the U.S. Food and Drug Administration (FDA) has granted approval for the first interchangeable biosimilars to Prolia (denosumab) and Xgeva (denosumab). Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) have been authorized as interchangeable biosimilars to the U.S.-licensed Prolia and Xgeva, respectively, offering promising treatment options for osteoporosis and bone complications from cancer.
Jubbonti, akin to Prolia, is indicated for the treatment of osteoporosis in specific patient populations. It has demonstrated efficacy comparable to that of Prolia in clinical trials. Common side effects of Jubbonti, similar to those observed with Prolia, include low blood calcium, back, joint, arm, leg, and muscle pain, common cold symptoms (such as runny nose or sore throat), and arthritis.
Similarly, Wyost, mirroring Xgeva, is designed for the treatment of bone complications arising from cancer. Clinical data supports its efficacy in addressing bone complications in cancer patients. The most frequent side effects of Wyost, consistent with those associated with Xgeva, encompass tiredness/weakness, low phosphate levels in the blood, diarrhea, nausea, low red blood cells, low blood platelets and calcium levels, back pain, swelling of the lower legs or hands, upper respiratory tract infection, rash, and headache.
The approval of these interchangeable biosimilars marks a significant advancement in providing patients with more accessible and cost-effective treatment options for osteoporosis and bone complications from cancer. Biosimilars play a crucial role in expanding patient access to critical medications while promoting competition and potentially reducing healthcare costs.
Dr. Janet Woodcock, Acting FDA Commissioner, emphasized the significance of interchangeable biosimilars in enhancing patient care and promoting health equity. “Interchangeable biosimilars offer patients greater flexibility in treatment options and contribute to fostering a competitive market, ultimately benefiting patients by increasing access to high-quality, affordable medications,” stated Dr. Woodcock.
The approval of Jubbonti and Wyost underscores the FDA’s commitment to facilitating the development and availability of biosimilar products, thereby fostering innovation and improving healthcare outcomes for patients nationwide. As these biosimilars become commercially available, they hold promise in transforming the landscape of osteoporosis and cancer treatment, offering patients and healthcare providers effective and affordable therapeutic options.
