Samsung Bioepis said it has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for marketing authorization of Obodence and Xbryk, biosimilars of Amgen’s Prolia and Xgeva.

These biosimilars, developed under the project name SB16, are based on denosumab, an active ingredient used to treat osteoporosis and skeletal-related conditions.

Prolia and Xgeva, developed by Amgen, have been approved for different indications. Prolia targets osteoporosis, while Xgeva is used for the prevention of skeletal-related events (SREs) in patients with bone metastases and for treating giant cell tumors of bone. In 2022, the combined global sales of these two products reached approximately 8 trillion won ($5.7 billion).

Samsung Bioepis received CHMP’s recommendation for marketing authorization of Obodence as a Prolia biosimilar and Xbryk as an Xgeva biosimilar. The company expects final approval from the European Commission (EC) within two to three months, a step that will officially allow the products to enter the European market.

The company had conducted a global phase 3 clinical trial for SB16 between November 2020 and December 2022, involving 457 postmenopausal osteoporosis patients across five countries, including Korea. The results showed equivalence in efficacy and safety compared to their reference drugs, Prolia and Xgeva.

Additionally, clinical data from phase 1 and phase 3 trials were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in October 2022, demonstrating the clinical comparability of SB16 to the original medications.

"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,” Samsung Bioepis Regulatory Affairs Vice President Jung Byung-in said.

Meanwhile, Samsung Bioepis has already introduced eight biosimilars in Europe, addressing therapeutic areas such as oncology, autoimmune diseases, and ophthalmology. If Obodence and Xbryk secure EC approval, the company will expand its biosimilar portfolio in Europe to 11 products, following the CHMP’s recommendation in September for Opuviz, its aflibercept biosimilar for ophthalmological diseases.