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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.
Adalimumab Biosimilar Switching Policy Shows Long-Term Success in IBD
February 26th 2025Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study.
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.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Disease Activity, Safety Remain Following Switch From Infliximab Biosimilar to Remicade in IBD
February 15th 2025Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.
