Ustekinumab settlement
Fresenius Kabi and Formycon have reached a settlement with J&J and now, their biosimilar, FYB202, can be marketed in the US, subject to regulatory approval, no later than 15 April 2025. The two companies have confirmed that they are on track to submit their biologics license application (BLA) later in 2023.

This is now the third settlement that J&J have reached regarding ustekinumab biosimilars of their originator Stelera. The previous two were against Amgen, and Alvotech-Teva Pharmaceuticals. These were settled in May and June 2023, respectively [1].

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 [2].

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 [3] and Dong A ST [3, 4].

Alvotech-Teva advances
Alvotech and Teva entered a strategic partnership in August 2020 [5], under the terms of which they aimed to develop and bring to market several biosimilars, including a ustekinumab candidate. 

The partners will continue working closely on matters concerning pending approval in the US for AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab) [6]. The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, another proposed biosimilar for Stelara (ustekinumab), which is pending US Food and Drug Administration (FDA) approval.

The new expansion of the strategic partnership agreement pertains to exclusive US commercialization by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech. The agreement includes milestone payments. Teva and Alvotech will share profit from the commercialization of the biosimilars. Other financial terms and product details are confidential.

The agreement also includes increased involvement by Teva regarding manufacturing and quality at Alvotech’s manufacturing facility in Iceland and the two are collaborating to ensure the site is ready for FDA inspection.

In addition, Teva has agreed to acquire subordinated convertible bonds to be issued by Alvotech, for US$40 million. 

Related articles
EMA accepts application for ustekinumab biosimilar AVT04 

Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics 

References
1. GaBI Online - Generics and Biosimilars Initiative. J&J lawsuits settled over ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 8]. Available from:
www.gabionline.net/pharma-news/j-j-lawsuits-settled-over-ustekinumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 8]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
3. GaBI Online - Generics and Biosimilars Initiative. Korean biosimilars makers pipelines and expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 8]. Available from:
www.gabionline.net/pharma-news/Korean-biosimilars-makers-pipelines-and-expansion
4. GaBI Online - Generics and Biosimilars Initiative. Trials of ustekinumab biosimilars advance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 8]. Available from: www.gabionline.net/biosimilars/news/Trials-of-ustekinumab-biosimilars-advance
5. GaBI Online - Generics and Biosimilars Initiative. Teva changes course in Japan and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 8]. Available from: www.gabionline.net/pharma-news/Teva-changes-course-in-Japan-and-the-US
6. GaBI Online - Generics and Biosimilars Initiative. Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 8]. Available from: www.gabionline.net/biosimilars/news/alvotech-rejection-avt02-in-the-us-and-new-partnerships-with-prolifarma-and-advanz-pharma

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2023 Pro Pharma Communications International. All Rights Reserved.