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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.
Etanercept Biosimilar Switch Shows Stable Outcomes and Disease Control in RA
May 13th 2025Patients with rheumatoid arthritis (RA) who switched from Enbrel (reference etanercept) to a biosimilar maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.
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.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
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.
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.
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.
