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.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.
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.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.
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.
AAD Posters Examine Clinical Effects of Switching to Ustekinumab, Adalimumab Biosimilars
March 20th 2024Two posters presented at the American Academy of Dermatology (AAD) annual meeting examined the effects of switching from reference ustekinumab and adalimumab to biosimilar versions in patients with different types of psoriasis.
Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake
March 18th 2024Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.