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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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.
