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Samsung Bioepis Initiates Phase 3 Trial for Denosumab Biosimilar
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.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Early Success of Adalimumab Biosimilars Featured at AMCP 2025
April 5th 2025High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).
Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD
April 3rd 2025The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.
