Johnson & Johnson (J&J), the maker of Stelara (ustekinumab), settled two lawsuits, one against Amgen, and the other against Alvotech and Teva Pharmaceuticals. Both lawsuits were over proposed ustekinumab biosimilars for the treatment of autoimmune conditions. These were settled in May and June 2023,respectively.
The settlement terms are confidential in both cases, however, for Amgen it has been revealed that the results will delay the anticipated launch date of its biosimilar, pending US Food and Drug Administration (FDA) approval, from late 2023, when the patent expires in the US [1], to January 2025. For the Alvotech-Teva partnership the settlement grants a license entry date for their biosimilar (AVT04) in the US no later than 21 February 2025. The Alvotech’s AVT04 product licence application has already been accepted in Europe [2].
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 [3].
Patents expire for Stelera in Europe in 2024 and there are a number of other ustekinumab biosimilars in the pipeline. These are being developed by companies such as Celltrion [4], Fomycon [5] and Dong A ST [6].
This is not the first time Amgen has been involved in a lawsuit. In 2019, Amgen reached a settlement agreement with the federal government in the US, to resolve civil claims relating to certain financial donations made Amgen to certain independent charity patient assistance foundations prior to 2017. Under the agreement, Amgen was asked to pay US$24.75 million to the government to resolve claims.
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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. EMA accepts application for ustekinumab biosimilar AVT04[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 24]. Available from: www.gabionline.net/biosimilars/news/ema-accepts-application-for-ustekinumab-biosimilar-avt04
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
4. GaBI Online - Generics and Biosimilars Initiative. Korean biosimilars makers pipelines and expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 24]. Available from: www.gabionline.net/Pharma-News/Korean-biosimilars-makers-pipelines-and-expansion
5. 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 2023 Jul 24]. Available from: www.gabionline.net/Biosimilars/News/Phase-I-trials-started-for-aflibercept-and-ustekinumab-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. Trials of ustekinumab biosimilars advance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 24]. Available from: www.gabionline.net/Biosimilars/News/Trials-of-ustekinumab-biosimilars-advance
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