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.
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.
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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 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
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