Enters Commercialization Phase with EU Approval

On February 12, 2025, the European Commission (EC) approved Obodence (denosumab) from Samsung Bioepis. This follows the positive opinion adopted on November 14, 2024, by the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP), leading to formal marketing authorization. The marketing authorization holder is Samsung Bioepis NL B.V., and the approval stage has progressed to the Marketed stage based on direct sales in Europe. This represents a significant milestone for Samsung Bioepis, demonstrating its transition into an integrated biopharmaceutical company with capabilities spanning development, approval, and sales, reducing its reliance on partners.

RANKL Inhibitor Biosimilar to Prolia

Obodence, with the development code SB16, is a 60mg pre-filled syringe formulation and a monoclonal antibody biosimilar referencing Amgen (AMGN)'s Prolia (denosumab). Denosumab inhibits the formation and activity of osteoclasts by blocking the receptor activator of nuclear factor kappa-B ligand (RANKL), and is administered subcutaneously every six months. Its indications include osteoporosis in postmenopausal women and men at high risk of fracture, bone loss associated with prostate cancer hormone deprivation therapy, and bone loss associated with long-term systemic glucocorticoid treatment. It is contraindicated in patients with hypocalcemia and requires a patient card to inform about calcium and vitamin D supplementation and the risk of osteonecrosis of the jaw.

457-Patient Phase 3 Trial Demonstrates Equivalence

NCT04664959, a Phase 3 trial, was a double-blind, multi-center study that randomized 457 postmenopausal women with osteoporosis in a 1:1 ratio to receive SB16 or Prolia. After 12 months, lumbar spine bone mineral density increased by approximately 5.7% in the Obodence group and 5.3% in the Prolia group, supporting clinical equivalence. The trial began in November 2020 and was completed in January 2023. From 12 months onwards, the study compared a Prolia continuation group with an SB16 switch group, evaluating efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity over a total of 18 months. This switch design provides evidence not only for new patients but also for switching existing Prolia prescriptions to the biosimilar.

Competing in a $6.6 Billion Annual Market

In 2024, Amgen's global sales were USD 4.374 billion for Prolia and USD 2.225 billion for Xgeva (denosumab), a similar product for oncological bone diseases, totaling USD 6.599 billion. Sandoz (SDZ.SW)'s Jubbonti (denosumab), a direct competitor, received EU approval earlier on May 16, 2024. Bisphosphonates such as alendronate, risedronate, and zoledronic acid, as well as bone-forming agents such as romosozumab and teriparatide, are also standard treatment options. In the United States, Ospomyv (denosumab-dssb), a similar product, received FDA approval on February 13, 2025, expanding regional diversification. Obodence's sales performance will be determined not only by the approval itself but also by factors such as national reimbursement listing, hospital tender prices, stable supply, and the speed of switching Prolia prescriptions.