Japanese approval for first ustekinumab biosimilar

Biosimilars/News | Posted 24/10/2023 post-comment0 Post your comment

Iceland-based biosimilar manufacturer Alvotech announced on 25 September 2023 that its commercialization partner in Japan, Fuji Pharma Co Ltd (Fuji) had received marketing approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its ustekinumab biosimilar AVT04 in Japan.

Ustekinumab MOA V21F04

The product is the first ustekinumab biosimilar to be approved in Japan. 

Ustekinumab is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis, and the originator is Janssen’s Stelara. It 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 [1]. 

AVT04 has secured its first global approval in Japan and marks the initial biosimilar to be granted regulatory authorization under the Alvotech and Fuji partnership [2]. Under the terms of the partnership established in November 2018, Alvotech is responsible for development and manufacturing and Fuji Pharma has exclusive commercialization rights in Japan. AVT04 joins a growing roster of approved biosimilars in Japan, emphasizing the partnership's milestone achievement [3].

‘We are thrilled to receive marketing approval for AVT04 in Japan, which will be Alvotech’s second marketed biosimilar,’ said Robert Wessman, chairman and CEO of Alvotech. ‘Alvotech and Fuji have a joint commitment to increase patient access to vital biologic medicines, and based on our strong partnership, we believe we will be able to serve the growing need for biosimilars in Japan’.

Regarding the ustekinumab biosimilar’s position in the rest of the world, the patents on Stelara expired in the US in September 2023 and will expire in Europe in January 2024 [4]. Alvotech’s AVT04 was accepted for review by the European Medicines Agency [5] and the US Food and Drug Administration in early 2023 [6].  In the US, the product is to be launched with marketing partner Teva, whereas in Europe the marketing partnership is with Stada. Alvotech is also partnered with Cipla Gulf to bring the product to market in emerging markets in Arabia and Africa [7].

Related articles
Long-term data support the clinical comparability of AVT04 to Stelara

Clinical trials begin for ustekinumab biosimilars 

Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Global marketing and commercialization advances for Alvotech and partners [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 24]. Available from: www.gabionline.net/pharma-news/global-marketing-and-commercialization-advances-for-alvotech-and-partners
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 24]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-Japan
4. 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
5. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for ustekinumab biosimilar AVT04 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 24]. Available from: www.gabionline.net/biosimilars/news/ema-accepts-application-for-ustekinumab-biosimilar-avt04
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 24]. Available from: www.gabionline.net/biosimilars/news/biosimilar-advances-for-alvotech-teva-and-setback-for-biocon-biologics
7. GaBI Online - Generics and Biosimilars Initiative. Alvotech and Cipla Gulf partnership announced [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 24]. Available from: www.gabionline.net/pharma-news/Alvotech-and-Cipla-Gulf-partnership-announced

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