Samsung Bioepis advances biosimilars development with CHMP recommendation
Following successful global clinical trials, Samsung Bioepis received a CHMP recommendation for two biosimilars of denosumab, facilitating their market entry across Europe.
As the patent for Amgen’s (CA, USA) Prolia® and Xgeva® (denosumab) approaches expiration in 2025, companies in key markets are planning to launch biosimilars. Samsung Bioepis (Incheon, South Korea) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Obodence™ as a biosimilar of Prolia and Xbryk™ as a biosimilar of Xgeva. These new biosimilars could offer increased accessibility and reduced healthcare costs in diverse populations for the treatment of osteoporosis, cancer and rare bone diseases.
Denosumab, currently sold under the brand names Prolia and Xgeva, is a monoclonal antibody that targets RANKL, a protein responsible for regulating the activity of osteoclasts (bone cells that dissolve old and damaged bone tissue). By inhibiting RANKL, denosumab prevents bone breakdown, strengthens bones and reduces the risk of fractures. It is used to treat secondary bone cancer, prevent bone fractures and slow bone damage in individuals with giant cell tumors of the bone.
With osteoporosis affecting one in three women and one in five men over 50 globally, and skeletal-related events such as fractures and spinal cord compression posing serious challenges for patients with bone metastases, introducing new biosimilars of denosumab is pivotal for increasing accessibility and providing cost-effective yet equally efficacious treatment alternatives to Prolia and Xgeva.
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Prolia and Xgeva are approved for distinct indications. Prolia is designed to treat osteoporosis, while Xgeva is used to prevent skeletal-related events in patients with bone metastases and to treat giant cell tumors of the bone.
Samsung Bioepis has achieved a significant advancement in biosimilars development. The company recently conducted a global phase 3 clinical trial for Obodence and Xbryk from 2020–2022, with 457 postmenopausal osteoporosis patients across five countries. Their phase 1 to phase 3 clinical data and results were showcased at the American Society for Bone and Mineral Research Annual Meeting in 2022 (9–12 September; TX, USA), demonstrating equivalent efficacy and safety to the original drugs Prolia and Xgeva.
Following the recent CHMP recommendation for marketing authorization, Samsung Bioepis anticipates receiving final approval from the European Commission (Brussels, Belgium) in the next three months. Their products will then officially enter the European market.
The company has already introduced eight biosimilars in Europe. With the anticipated approval of Obodence and Xbryk, as well as Opuviz™ (an aflibercept biosimilar for ophthalmological diseases), its biosimilar portfolio will cover 11 products across cancer, autoimmune diseases and ophthalmology.
“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,” commented Byungin Jung, the Regulatory Affairs Vice President at Samsung Bioepis.
