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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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
