Ustekinumab is a monoclonal antibody treatment for psoriasis and inflammatory bowel disease. The drug works by suppressing inflammatory cytokines (IL-12 and IL 23) so they cannot bind to their receptors. The originator product, Johnson & Johnson’s Stelara (ustekinumab), had worldwide sales of US$6.4 billion in 2019. The patents on Stelara will expire in the US in September 2023 and in Europe in January 2024 [1].

Various companies, including NeuClone [2], Formycon [3], Bio-Thera [4] and Alvotech [5] are working on a biosimilar of the drug.

Meiji Seika Pharma and Dong-A can now be added to that list, as they announced in December 2019 the start of a phase I clinical trial for their own ustekinumab biosimilar.

The trial is a randomized, double-blind, three-arm, single-dose study to compare the pharmacokinetics, safety and tolerability of the biosimilar (DMB 3115) with US and EU reference products. It is taking place at a single site in Europe in healthy volunteers.

The product has been manufactured by Korea-based DM Bio, a joint venture between Meiji Seika Pharma and Dong-A, which was established in 2011.

They may face strong competition to their biosimilar as German biosimilars company Formycon say they have already achieved ‘key milestones’ in the development of their biosimilar and expect to launch the drug once patents on Stelara have expired. Likewise, NeuClone began a large multi-site trial of their biosimilar in October 2019 [6], subject visits for which were completed in April 2020.

NeuClone announced in April 2020 that phase I patient monitoring and blood sampling has been completed for its ustekinumab biosimilar, NeuLara. So far, over 200 healthy volunteers have received a single dose of either NeuLara, or US- or EU-sourced reference product Stelara. Volunteers were monitored for up to 105 days, with blood samples collected for pharmacokinetics and anti-drug antibody testing.

Early analysis of the data suggests the compound is safe and tolerable. Dr Noelle Sunstrom, CEO and Founder of NeuClone, said in a statement: ‘We are delighted with the progress of NeuLara through its phase I clinical trial. Our attention now shifts to the final stages of development required for approval and supply of NeuLara to patients globally’.

The final clinical study report is anticipated in the third quarter of 2020.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003 
2. GaBI Online - Generics and Biosimilars Initiative. NeuClone to start phase I trial for ustekinumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Biosimilars/News/NeuClone-to-start-phase-I-trial-for-ustekinumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Phase I trials started for aflibercept and ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Biosimilars/News/Phase-I-trials-started-for-aflibercept-and-ustekinumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-gains-Chinese-approval-for-adalimumab-copy-biological-and-starts-ustekinumab-trial
5. GaBI Online - Generics and Biosimilars Initiative. Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Pharma-News/Alvotech-signs-agreement-for-ustekinumab-biosimilar-Stelara-in-Japan
6. GaBI Online - Generics and Biosimilars Initiative. NeuClone progress with ustekinumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Biosimilars/Research/NeuClone-progress-with-ustekinumab-and-trastuzumab-biosimilars

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