Samsung Launches Clinical Study of Denosumab Candidate

The company is targeting the lucrative osteoporosis market dominated by Prolia, an Amgen product.

Samsung Bioepis said it has initiated a phase 1 clinical trial for its denosumab biosimilar candidate (SB16) for osteoporosis.

The proposed biosimilar references Amgen’s blockbuster Prolia, which in the third quarter of 2020 garnered $701 million in revenues, up 11% from the comparable year-ago quarter.

Prolia was first approved for osteoporosis with high risk of fracture in 2010 and has been approved for multiple indications since, including bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, bone loss for men with osteoporosis and high fracture risk, and glucocorticoid-induced osteoporosis.

Samsung Bioepis, based in Incheon, Republic of Korea, said the trial is a randomized, double-blind, 3-arm, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity between SB16 and reference denosumab in a target population of 168 healthy male participants.

The 3 study arms will involve dosing with SB16 or either the EU or US versions of the reference product.