Samsung Bioepis Receives Positive EMA Opinion for Denosumab Biosimilars Obodence and Xbryk
核心洞察
Samsung Bioepis (搜索) received a positive CHMP opinion for Obodence and Xbryk, biosimilars of Amgen's Prolia and Xgeva, respectively, targeting osteoporosis (搜索) and skeletal-related conditions.
Clinical trials, including a global Phase 3 study, demonstrated the equivalence of SB16 (denosumab biosimilar) to Prolia and Xgeva in terms of efficacy and safety.
The European Commission is expected to grant final approval within 2-3 months, potentially expanding Samsung Bioepis (搜索)' biosimilar portfolio in Europe to 11 products.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Samsung Bioepis (搜索)' Obodence and Xbryk, biosimilars of Amgen's Prolia (denosumab) and Xgeva (denosumab), respectively. These biosimilars, developed under the project name SB16, target osteoporosis (搜索) and skeletal-related conditions, offering a potentially more affordable treatment option for patients.
Clinical Trial Equivalence
Samsung Bioepis (搜索) conducted a global Phase 3 clinical trial (November 2020 - December 2022) involving 457 postmenopausal women with osteoporosis (搜索) across multiple countries, including Korea. The trial results demonstrated equivalent efficacy and safety profiles between SB16 and the reference drugs, Prolia and Xgeva. Further clinical data from Phase 1 and Phase 3 trials, presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in October 2022, reinforced the clinical comparability of SB16 to the original medications.
Indications and Market Opportunity
Prolia is approved for treating osteoporosis (搜索), while Xgeva is indicated for preventing skeletal-related events (SREs) in patients with bone metastases (搜索) and for treating giant cell tumors of bone (搜索). The combined global sales of Prolia and Xgeva reached approximately 8 trillion won ($5.7 billion) in 2022, indicating a substantial market for biosimilars. With CHMP's positive recommendation for marketing authorization, Obodence is positioned as a Prolia biosimilar, and Xbryk as an Xgeva biosimilar.
Expansion of Biosimilar Portfolio
"The CHMP approval recommendation reaffirms our global-level R&D capabilities, and we will continue striving to provide more patients with treatment opportunities using biosimilars through our diverse product portfolio," said Jung Byung-in, Vice President of Regulatory Affairs at Samsung Bioepis (搜索). The European Commission is expected to grant final approval within the next two to three months, officially allowing the products to enter the European market. Samsung Bioepis currently markets eight biosimilars in Europe, addressing therapeutic areas such as oncology, autoimmune diseases, and ophthalmology. If Obodence and Xbryk receive EC approval, the company's biosimilar portfolio in Europe will expand to 11 products, following the CHMP's recommendation in September for Opuviz, its aflibercept biosimilar for ophthalmological diseases.