EMA accepts application for ustekinumab biosimilar AVT04

Biosimilars/News | Posted 03/03/2023 post-comment0 Post your comment

Alvotech announced on 9 February 2023 that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, their proposed biosimilar to Stelara (ustekinumab).

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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].

The patents on Stelara are due to expire in the US in September 2023 and in Europe in January 2024 [2]. Alvotech’s AVT04 has already been approved by the Food and Drug Administration in the US [3].  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 [4].

Alvotech and Stada hope that EMA will recommend approving a marketing authorization for AVT04 later in 2023.

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1. GaBI Online - Generics and Biosimilars Initiative.  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. 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
3. 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 Mar 3]. Available from: www.gabionline.net/biosimilars/news/biosimilar-advances-for-alvotech-teva-and-setback-for-biocon-biologics
4. GaBI Online - Generics and Biosimilars Initiative. Alvotech and Cipla Gulf partnership announced  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 3]. Available from:

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