Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis, and sold by originator company Janssen as Stelara.

In Australia, biosimilar manufacturer BioFactura Australia Pty Ltd (a subsidiary of the US firm BioFactura) announced in May 2021 the beginning of a phase I trial for a ustekinumab biosimilar, named BFI-751. The phase I trial will compare the pharmacokinetics of BFI-751 to originator ustekinumab in healthy volunteers and is the first time the biosimilar has been administered in humans. The trial has been authorized by the Ethics Committees in Australia and New Zealand and will be conducted at sites in both countries.

The randomized, double-blind trial will compare the pharmacokinetics of BFI-751 to US- and EU-Stelara following a single dose under the skin. The study will also assess the safety and tolerability of BFI-751, and the immune response it mounts, in 210 healthy volunteers. BioFactura reports that the first three sentinel groups have been dosed with no significant adverse events, allowing all three clinical sites to start accepting volunteers.

Dr Jeffrey Hausfeld, Chairman of the Board and Chief Medical Officer of BioFactura, said: ‘As a physician, it is exhilarating to be part of the journey at BioFactura. From biopharmaceutical research and development to manufacturing and the initiation of this pivotal trial, it is clear how much progress has been made. Given the prevalence and impact of autoimmune diseases on people across the globe, it is exciting to be taking the next step forward to making a positive impact on these patients’ lives. Dedicated scientific professionals at BioFactura, as well as our trusted Australian collaborators, Avance Clinical and Bentleys SA/NT, have made this milestone a reality’.

Dr Darryl Sampey, BioFactura’s President and CEO, added: ‘The initiation of this inaugural first-in-human study is an important milestone for BioFactura as it marks the beginning of clinical development of the first product candidate in our biosimilar pipeline’.

Following this news, on 6 July 2021 Icelandic biosimilars manufacturer Alvotech announced the start of their own clinical studies for a ustekinumab biosimilar, currently known as AVT04.

The trial is being conducted in parallel with a pharmacokinetic comparability study of AVT04 in healthy volunteers in New Zealand and Australia. It will confirm the efficacy and safety of AVT04 in moderate-to-severe plaque psoriasis, compared to the originator product (Stelara). The trial will involve approximately 530 participants and is being conducted across five countries in Central and Eastern Europe.

Mark Levick, CEO of Alvotech, said he was pleased to begin enrolling patients in the clinical trial, which he called an important milestone, adding: ‘[The] initiation of this clinical program, with two studies running in parallel, reinforces our commitment to improving the efficiency of the clinical development, with the ultimate goal of improving the lives of patients suffering from serious chronic or life-threatening diseases, through faster access to high quality biosimilars’.

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