EMA recommends approval of ustekinumab biosimilar Pyzchiva

Biosimilars/News | Posted 22/03/2024 post-comment0 Post your comment

On 22 February 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva (ustekinumab), a biosimilar of reference product Stelara.


Samsung Bioepis' Pyzchiva (also known as SB17) is a biosimilar of Johnson & Johnson’s originator Stelera. The patents for Stelera expired in the US in September 2023 and in Europe in January 2024 [1].  

Pyzchiva is the second ustekinumab biosimilar approved in the European Union, following Stada’s (Alvotech) Uzpruvo ustekinumab biosimilar, which received marketing authorization from the European Commission (EC) on 5 January 2024 [2]. In the US, Amgen’s Wezlana (ustekinumab-auub) was approved as the first interchangeable ustekinumab biosimilar Wezlana [3].

Several companies, such as Bio-Thera, Celltrion, Dong-A/Meiji Seika, Epirus, Formycon/Aristo Pharma, NeuClone/Serum Institute of India, are also involved in ustekinumab biosimilars development [4].

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 [4].

This new biosimilar, Pyzchiva, is intended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults. Pyzchiva will be available as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion. 

Following this EC positive opinion, if marketing authorization is granted, Pyzchiva would become Samsung Bioepis’ fourth immunology biosimilar. Pyzchiva will be commercialized by Sandoz as Samsung Bioepis and Sandoz have entered into a development and commercialization agreement for the ustekinumab biosimilar candidate in September 2023 for Canada, European Economic Area, Switzerland, UK and the US.

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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. EC approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 22]. Available from: www.gabionline.net/biosimilars/news/ec-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 Mar 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Mar 22]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab

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