Samsung Bioepis Initiates Phase 3 Trial for Denosumab Biosimilar

Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

Samsung Bioepis hopes to gain regulatory approval for a denosumab biosimilar referencing Prolia. The trial will focus on women with postmenopausal osteoporosis.

Samsung Bioepis has initiated a phase 3 trial for a proposed denosumab biosimilar (SB16) referencing Prolia. The randomized, double-blind, multicenter study will evaluate SB16 for equivalent efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity in a population of 432 women with postmenopausal osteoporosis.

Samsung Bioepis also began a phase 1 trial in October 2020 evaluating the same parameters for SB16 in healthy volunteers. In addition to SB16, the company has 2 other biosimilar candidates in development: eculizumab (SB12) and aflibercept (SB15).

In November 2020, Samsung Bioepis and Biogen announced the FDA had accepted their application for a ranibizumab biosimilar candidate (SB11) referencing Lucentis. Ranibizumab is a vascular endothelial growth factor agent intended for treatment of retinal vascular disorders.

Also in November 2020, Samsung Bioepis announced 1-year findings from a phase 3 study of SB11 in patients with neovascular age-related macular degeneration. The data presented at the American Academy of Ophthalmology 2020 meeting, held virtually this year, confirmed that SB11 has equivalent efficacy, safety, immunogenicity, and PK to the reference product.

The investigators said 634 patients of 705 enrolled completed the study up to week 52. Primary end points, defined as changes from baseline in best corrected visual acuity at week 8 and central subfield thickness at week 4, were met. They said efficacy, safety, PK, and immunogenicity were comparable to the reference product.