EC approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 16/01/2024 post-comment0 Post your comment

On 5 January 2024, the European Commission (EC) granted marketing authorization for the first ustekinumab biosimilar Uzpruvo (AVT04). The biosimilar of Uzpruvo is developed by Iceland-based biosimilar manufacturer Alvotech.

IBD 1

On 10 January 2024, partners Stada and Alvotech announced that its ustekinumab biosimilar, Uzpruvo (AVT04), had received EC approval. This is now the first and only ustekinumab biosimilar available in Europe. It is a biosimilar of Janssen’s Stelara.

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 [1].  

The EC approval follows a positive opinion issued on 9 November 2023 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union (EU) Member States plus Iceland, Norway and Liechtenstein [2].

The approval of Uzpruvo's European marketing authorization sets the stage for prompt market entry after the expiration of the European Supplementary Protection Certificate (SPC) for Stelara in July 2024 [2].

Through a strategic collaboration since 2019, Alvotech is responsible for the development and production of AVT04.  Stada possesses commercial rights of AVT04 within Europe, where the company already markets six approved biosimilars: teriparatide Movymia; adalimumab Hukyndra; pegfilgrastim Cegfila*; epoetin zeta Silapo; bevacizumab Oyavas; ranibizumab Ximluci. 

In the US, in October 2023, the US Food and Drug Administration (FDA) approved the first interchangeable ustekinumab biosimilar, Wezlana ((ustekinumab-auub) by Amgen [3], and issued a complete response letter (CRL) for Alvotech’s Biologics License Application for AVT04 [4].

*STADA markets the Cegfila pegfilgrastim biosimilar (previously Pegfilgrastim Mundipharma) under license in certain countries, predominantly Germany.

Related articles
Japanese approval for first ustekinumab biosimilar

J&J lawsuits settled over ustekinumab biosimilars

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Consulta pública para la modificación de la regulación de biosimilares

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Consulta pública para la modificación de la regulación de biosimilares

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 16]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 16]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-ustekinumab-biosimilar-uzpruvo
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 16]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
4. GaBI Online - Generics and Biosimilars Initiative. Alvotech biosimilars: FDA ustekinumab application rejection; adalimumab interchangeability designation re-submission [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jan 16]. Available from: www.gabionline.net/biosimilars/news/alvotech-biosimilars-fda-ustekinumab-application-rejection-adalimumab-interchangeability-designation-re-submission

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 © 2024 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
EC approval of trastuzumab biosimilar Herwenda
Cancer image015
Biosimilars/News Posted 23/01/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010