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On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen's PROLIA and XGEVA, respectively. As recited in the announcement, "[d]enosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of the bone."
Under a license and commercialization agreement entered into in 2021, Richter will manufacture the products and Hikma will exclusively commercialize them in the United States. As we reported previously, the FDA approved the denosumab biosimilars in September 2025.
Hikma, Richter, and Amgen settled their BPCIA litigation concerning ENOBY and XTRENBO in November 2025.
Stay tuned to Big Molecule Watch and follow our BPCIA Litigations Tracker to stay up to date on denosumab and other BPCIA litigation news.
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