Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.
Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.
The study compares the pharmacokinetics and safety of BAT2506 to golimumab sourced from the European Union, with each participant receiving either a single subcutaneous dose of BAT2506 or golimumab. The randomized, double-blind, 2-arm, parallel group study is expected to enroll about 182 healthy volunteers.
“Initiating our [phase 1] clinical trial for BAT2506, our proposed biosimilar for Simponi, represents the fourth biosimilar that Bio-Thera has advanced into clinical trials,” said Shengfeng Li, chief executive office of Bio-Thera Solutions, in a statement. “Bio-Thera is committed to bringing safe and effective biosimilars to patients around the world.”
The brand-name Simponi, developed by Janssen, is FDA approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (AS), and ulcerative colitis. An anti—tumor necrosis factor therapy, golimumab is administered via a subcutaneous injection. Another formulation of golimumab, sold as Simponi Aria, is available for intravenous infusion.
Worldwide, Janssen saw sales of $563 million from the 2 formulations of Simponi, up 2.7% from the same quarter in 2018.
Bio-Thera Solutions is also developing other proposed biosimilars. Its proposed adalimumab biosimilar, BAT1406, recently met its primary end point of equivalent efficacy to reference adalimumab, Humira, in a phase 3 trial conducted in patients with active AS.
It is also developing a proposed bevacizumab biosimilar, BAT1706, referencing Avastin, and BAT1806, a proposed tocilizumab (Actemra) biosimilar. BAT1806 is also in a phase 3 trial.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
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.
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.
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.
Pharmacokinetic Modeling Proposes Cost-Effective Dosing for Adalimumab, Etanercept Biosimilars
October 12th 2024A UK cohort study used drug concentration samples from rheumatoid arthritis patients starting the adalimumab biosimilar Amgevita and the etanercept biosimilar Benepali to simulate drug levels under standard and alternate dosing schedules, suggesting that personalized dosing could reduce costs while potentially increasing efficacy.