FDA approves first interchangeable ustekinumab biosimilar Wezlana

Biosimilars/News | Posted 07/11/2023 post-comment0 Post your comment

On 31 October 2023, the US Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Substitution V13F14

Wezlana has been developed by Amgen and is the first approved biosimilar of Stelara in the US.

Johnson & Johnson’s (J&J) patents for Stelara expired in the US in September 2023 and are set to expire in Europe in January 2024 [1]. There are several ustekinumab biosimilars in development by companies like Alvotech, Celltrion, Fomycon and Dong A ST.

Early in 2023, Amgen and J&J reached an agreement to delay its projected launch date for Wezlana from late 2023 to ‘no later than 1 January 2025’ [2]. Similar agreements have been set up between J&J and other companies developing biosimilars of ustekinumab [3].

The interchangeability designation will allow for Wezlana to substitute for Stelara at the pharmacy level without requiring a pharmacist to get permission from a provider first [4]. Wezlana is the seventh biosimilar in the US to be given this designation, following Abrilada (adalimumab-afzb), Byooviz (ranibizumab-runa), Cimerli (ranibizumab-eqrn), Cyltezo (adalimumab-adbm), Rezvoglar (insulin glargine-aglr), and Semglee (insulin glargine-yfgn).

The interchangeability designation is designed to increase access to the biosimilar and convenience for patients.  

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 [5].  

On 25 September 2023, Alvotech’s AVT04 became the first ustekinumab biosimilar to be approved in Japan. In February 2023, the European Medicines Agency has accepted the Marketing Authorization Application for AVT04, and in the summer of 2023, CuraTeQ Biologics has entered into an exclusive license agreement to commercialize BFI-751, BioFactura’s proposed biosimilar ustekinumab.

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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. J&J lawsuits settled over ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 7]. Available from: www.gabionline.net/pharma-news/j-j-lawsuits-settled-over-ustekinumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 7]. Available from: www.gabionline.net/pharma-news/fresenius-kabi-and-formycon-reach-agreement-with-j-j-alvotech-and-teva-expand-partnership
4. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 7]. Available from: www.gabionline.net/biosimilars/general/FDA-releases-new-information-on-interchangeable-biologicals
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 7]. Available from:

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