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Eye on Pharma: Bio-Thera's Adalimumab Biosimilar Meets Primary End Point in Phase 3 Study


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.


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.

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