NeuClone to start phase I trial for ustekinumab biosimilar

Biosimilars/News | Posted 31/05/2019 post-comment0 Post your comment

Australian biologicals company NeuClone announced on 15 May 2019 that it would start a phase I clinical trial of its ustekinumab biosimilar, NeuLara, in the second half of 2019.

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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.

The multicentre phase I trial of NeuLara will be conducted in Australia under the Clinical Trial Notification (CTN) scheme of the Therapeutic Goods Administration (TGA). The trial will be a three-arm, randomized, double-blind, single-dose study comparing the pharmacokinetics and safety of NeuLara, to US- and EU-sourced originator ustekinumab, Stelara, in healthy volunteers.

NeuClone has a pipeline of 10 biosimilars, including denosumab, palivizumab, pertuzumab and trastuzumab, which it is developing in collaboration with manufacturing partner Serum Institute of India [1]. The company’s trastuzumab biosimilar, NeuCeptin, has recently completed dosing in a three-arm phase I clinical trial being carried out in healthy male volunteers in Australia.

Other companies reported to be working on ustekinumab biosimilars or non-originator biologicals include China-based Bio-Thera Solutions, Swiss-based BioXpress Therapeutics and US/Netherlands collaboration Epirus Biopharmaceuticals/Bioceros Holding. In addition, Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 9 April 2019 that they had made a binding agreement for the exclusive partnership and supply to commercialize Alvotech’s ustekinumab biosimilar, Stelara, in Japan [2]. On 13 May 2019, Germany-based Formycon announced that its ustekinumab biosimilar (FYB202), which the company has developed with Aristo Pharma, had achieved ‘key milestones’ in the ‘pilot phase’ of its development. The company plans to start a phase I clinical trial in mid-2019.

1. GaBI Online - Generics and Biosimilars Initiative. Denosumab biosimilar being developed in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from:

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Source: ANZCTR, Formycon, NeuClone

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