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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.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
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?
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
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.
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.
