EMA recommends approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 14/11/2023 post-comment0 Post your comment

On 9 November 2023, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uzpruvo (ustekinumab), a biosimilar of reference product Stelara, intended for the treatment plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.


Ustekinumab is a human IgG1k monoclonal antibody used as a biological therapy in the fields of gastroenterology, dermatology and rheumatology.

This marks the first approved biosimilar of Stelara in Europe and follows Amgen’s first interchangeable ustekinumab biosimilar, Wezlana, which was approved by the US Food and Drug Administration (FDA) on 31 October 2023 [1].

The originator product, Johnson & Johnson’s Stelara (ustekinumab), was approved by FDA on 25 September 2009 and by the European Medicines Agency (EMA) on 15 January 2009 [2]. 

The applicant for Uzpruvo, Stada Arzneimittel AG, is in a strategic partnership with Iceland-based Alvotech [3], which is responsible for developing and manufacturing the AVT04 ustekinumab biosimilar. The AVT04 biosimilar drug applications were accepted by European Medicines Agency in February 2023 [4], while it received a complete response letter from FDA in October 2023 [5].  

This is not the first approval for AVT04; it received approval in Japan in September 2023 as the first ustekinumab biosimilar [6].

The positive CHMP opinion for Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data. This included data from the AVT04-GL-301 confirmatory clinical, safety and efficacy study that met its primary endpoint, with results demonstrating therapeutic equivalence between AVT04 and Stelara in patients with moderate to severe chronic plaque-type psoriasis. 

Uzprovo will be available as 45 mg and 90 mg solutions for injection.

Stada holds 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.

Stelara had worldwide sales of US$9.1 billion in 2021 and ranked 8th among the top 20 drugs.  With around 95,000 patients already using ustekinumab in the top 4 EU markets plus the UK, Stelara ranks among Europe’s top 10 medicine brands by value with annual sales in excess of €2.5 billion.  

Although Uzpruvo obtained the first approval for ustekinumab biosimiar in Europe, at least three other biosimiars are on the way to enter the market and enhance competition.  The Stelara biosimilar marketing authorization application submission accepted by EMA are Dong-A ST’s DMB-3115 and Fresenius Kabi and Formycon’s FYB202 announced on 14 July and 29 September, respectively.  Meanwhile, Samsung Bioepis’ SB17 ustekinumab biosimilar has completed phase I studies, the results of which were presented at the AAD in March 2023.

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

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

J&J lawsuits settled over ustekinumab biosimilars

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1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 14]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
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. Global marketing and commercialization advances for Alvotech and partners [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 14]. Available from: www.gabionline.net/pharma-news/global-marketing-and-commercialization-advances-for-alvotech-and-partners
4. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for ustekinumab biosimilar AVT04 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 14]. Available from: www.gabionline.net/biosimilars/news/ema-accepts-application-for-ustekinumab-biosimilar-avt04
5. 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 2023 Nov 14]. Available from: www.gabionline.net/biosimilars/news/alvotech-biosimilars-fda-ustekinumab-application-rejection-adalimumab-interchangeability-designation-re-submission
6. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for first ustekinumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 14]. Available from: www.gabionline.net/biosimilars/news/japanese-approval-for-first-ustekinumab-biosimilar

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