Ustekinumab, sold under the brand name Stelara by originator firm Janssen Pharmaceuticals, is a monoclonal antibody indicated for the treatment of a number of inflammatory conditions including inflammatory bowel disease (IBD), plaque psoriasis, and psoriatic arthritis. It works by targeting the inflammatory molecules IL-12 and IL-23.

Amgen is developing a biosimilar version of ustekinumab, currently named ABP 654. On 18 April 2022, the firm announced preliminary results from a phase III trial evaluating the efficacy and safety of ABP 654 compared to Stelara in adults with moderate to severe plaque psoriasis.

The trial met its primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and Stelara.

The primary analysis evaluated the percentage improvement from baseline to Week 12 of psoriasis area severity index (PASI), which showed a mean difference of percentage improvement between ABP 654 and Stelara of 0.14 (which was within pre-specified margins). The safety profile of ABP 654 was also comparable to Stelara.

David M Reese, MD, Executive VP of R & D at Amgen, commented: ‘Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines. We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options’.

Amgen currently has 11 biosimilars in its portfolio, including five that have been approved by the US Food and Drug Administration and three that are approved in the European Union. The firm recently discussed expectations of a ‘steady flow’ of biosimilar launches, including for ABP 654, as well as biosimilars for Eylea (aflibercept) and Soliris (eculizumab) [1].

Other firms developing ustekinumab biosimilars worldwide include Bio-Thera and Samsung Bioepis [2] and Japan-based Meiji Seika Pharma (Meiji) [3].

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Biosimilars of ustekinumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Amgen predicts a steady flow of biosimilar launches [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/general/amgen-predicts-a-steady-flow-of-biosimilar-launches
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/news/bio-thera-and-samsung-bioepis-start-clinical-trials-for-ustekinumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Meiji’s ustekinumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/research/positive-phase-i-results-for-meiji-s-ustekinumab-biosimilar

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