(Samsung Bioepis)

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Samsung Bioepis said on Tuesday it will begin direct sales of its bone disease biosimilars Obodence and Xbryk in Europe this month and in January 2026, accelerating its push into the European osteoporosis market.

Both are biosimilars of Amgen’s Prolia and Xgeva, based on the denosumab compound. Depending on dosage and indication, Obodence targets osteoporosis, while Xbryk treats giant cell tumors of the bone and other skeletal disorders.

With these two products, Samsung Bioepis has now commercialized 10 biosimilars in Europe in just a decade since the 2016 launch of Benepali, its Enbrel biosimilar.

The South Korean company conducted Phase 3 trials from November 2020 to January 2023 in 457 postmenopausal women, confirming equivalent efficacy and safety to the original products. Both drugs received regulatory approval in February 2025 in the U.S. and Europe.

Linda Choi MacDonald, executive vice president and global head of the Commercial Division at Samsung Bioepis, said the company was excited to introduce Obodence and Xbryk to Europe through direct commercialization. She added that the company aims to enhance treatment accessibility and help reduce healthcare costs through its biosimilars portfolio.