The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.
Bio-Thera’s proposed adalimumab biosimilar, BAT1406, has met its primary end point of equivalent efficacy to reference adalimumab, Humira, in a phase 3 trial conducted in patients with active ankylosing spondylitis.1
The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active AS. In total, 363 patients were randomized to receive the biosimilar and 191 were randomized to receive the reference.
At week 12 of the study, 75.69% of patients in the biosimilar arm and 73.68% of patients in the reference arm achieved an Assessment in Ankylosing Spondylitis (ASAS) of 20, or an absolute improvement of at least 10 units on a scale of zero to 100 (between group difference, 1.6%; 95% CI, —6.82% to 10.03%).
The frequency of adverse events between the biosimilar arm and the reference arm was 87.1% and 85.3%, respectively.
In August of 2018, Bio-Thera submitted an application for the biosimilar to China’s regulatory body, and it said that it expects the product to be the first biosimilar adalimumab approved in China.
The application submitted to the regulatory authorities includes a comprehensive data package that consists of analytical, preclinical, and clinical data. The clinical studies included a trial that investigated pharmacokinetic and pharmacodynamic data, as well as the phase 3 study in patients with AS. Bio-Thera says that it “believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy, and quality.”
Bio-Thera also reports that its pipeline contains biosimilar candidates of bevacizumab, which is currently being investigated in a global phase 3 clinical trial, as well as tocilizumab, ustekinumab, secukinumab, and golimumab.
Reference
Tu L, Wei Q, Xie Y, et al. Biosimilar BAT1406 versus adalimumab therapy on active ankylosing spondylitis: a randomized, double-blinded, multicenter, controlled phase 3 trial. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019; June 12-15, 2019; Madrid, Spain. Abstract FRI0415.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
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.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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.