- Company introduces Prolia and Xgeva Biosimilars 'Obodence' and 'Xbryk' in 무료 바카라 게임
- A decade after its first launch, ten commercialized products in 무료 바카라 게임, accelerating portfolio expansion
[by Kang, In Hyo] Samsung Bioepis announced on December 2 that it will begin direct commercialization of its two bone disease treatments, ‘Obodence’ and ‘Xbryk,’ in Europe, with launches scheduled sequentially in December and in January 2026.
‘Obodence-Xbryk’ is a biosimilar to ‘Prolia-Xgeva,’ developed by the global biopharmaceutical company Amgen. Depending on the dosage and dosing interval of the active ingredient denosumab, the product is offered in two formulations: ‘Obodence’ for osteoporosis and ‘Xbryk’ for giant cell tumors of bone.
Since the European launch of Benepali (Enbrel biosimilar, etanercept) for autoimmune diseases, in 2016, Samsung Bioepis has commercialized a total of ten products in the European market over the past decade, expanding its portfolio across multiple therapeutic areas, including immunology, oncology, ophthalmology, and hematology. Building on its commercial capabilities and accumulated expertise in the region, Samsung Bioepis plans to ‘directly commercializa’ Obodence-Xbryk through a tailored strategy centered on its European subsidiary.
무료 바카라 게임 Bioepis previously directly commercialized Epysqli (Soliris biosimilar, eculizumab) for rare diseases, in the European market. By expanding its direct-sales portfolio to include Obodence-Xbryk, the company noted that it will be able to further broaden its opportunities to connect with patients and healthcare professionals across Europe.
"We have launched Obodence and Xbryk based on our global expertise in developing and commercializing biosimilars across diverse therapeutic areas. We will continue striving to expand treatment options for patients through biosimilars and to enhance social value by helping reduce healthcare insurance costs," said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial Division at Samsung Bioepis.
On the other hand, 무료 바카라 게임 Bioepis conducted a global Phase 3 clinical trial of Obodence and Xbryk in 457 postmenopausal patients with osteoporosis from November 2020 to January 2023, demonstrating clinical equivalence in terms of efficacy and safety, compared with the reference products. Obodence and Xbryk received marketing approval in both the United States and Europe in February.