Samsung Bioepis has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for its biosimilars Ovodence and Xbrick, referencing Amgen's Prolia and Xgeva, respectively. This decision paves the way for potential approval and market availability of these biosimilars in Europe.
Prolia (denosumab) is used to treat osteoporosis, while Xgeva (denosumab) is indicated to prevent skeletal-related events (SREs) in patients with bone metastases and to treat giant cell tumor of bone. As of last year, the combined global sales for Prolia and Xgeva reached $6.16 billion.
Samsung Bioepis's Ovodence is intended as a biosimilar for Prolia, targeting osteoporosis, and Xbrick as a biosimilar for Xgeva, addressing skeletal-related events and giant cell tumor. The CHMP's positive opinion suggests that these biosimilars have demonstrated comparable efficacy, safety, and immunogenicity to their reference products.
A global Phase 3 clinical trial, involving 457 postmenopausal women with osteoporosis across five countries including Korea, was conducted over approximately two years, starting in November 2020. The trial compared SB16 (the project name for both Ovodence and Xbrick) with the original denosumab. According to the company, the study demonstrated clinical equivalence between SB16 and the original drug, based on data presented at the American Society for Bone and Mineral Research (ASBMR) annual meeting last year.
"Through this European permit recommendation, we have demonstrated our global level of R&D capabilities," said Jeong Byeong-in, head of Samsung Bioepis RA (Regulatory Affairs) team. "We will continue to work to provide more patients with treatment opportunities using biosimilars with our portfolio of products."
Following the CHMP's positive opinion, the European Commission (EC) will conduct a final review, which typically takes two to three months, before granting official marketing authorization. If approved, Ovodence and Xbrick will expand Samsung Bioepis's biosimilar portfolio in Europe to a total of 11 products, following Opubiz (biosimilar Eylea) which received a positive opinion in September.
