The European Commission (EC) granted marketing authorization for three ustekinumab biosimilars: Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s Otulfi on 25 September 2024.
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 approvals come after the July 2024 news that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for Eksunbi, Fymskina, and Otulfi [2].
By end of September 2024, EC has approved a total of seven ustekinumab biosimilars, see Table 1.
| Table 1: EC-approved ustekinumab biosimilars by September 2024
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| Product name
|
Authorization date
|
Manufacturer/Company name
|
| Eksunbi
|
12 Sep 2024
|
Samsung Bioepis
|
| Fymskina
|
25 Sep 2024
|
Formycon AG
|
| Otulfi
|
25 Sep 2024
|
Fresenius Kabi
|
| Pyzchiva
|
22 Apr 2024
|
Samsung Bioepis
|
| Steqeyma
|
22 Aug 2024
|
Celltrion
|
| Uzpruvo
|
5 Jan 2024
|
Alvotech/Stada Arzneimittel AG
|
| Wezenla
|
20 Jun 2024
|
Amgen
|
| *Data updated 5 November 2024
|
Both Fymskina and Otulfi are developed by Formycon AG, Otulfi is also approved in the US [3], with Fresenius Kabi as the commercialization partner for Otulfi in Europe and the US.
Like Formycon, Samsung Bioepis’ also has two ustekinumab biosimilars approved in Europe: Eksunbi and Pyzchiva [4], with the latter also approved for commercialization in the US by Sandoz [5].
Related articles
EMA recommends approval of first ustekinumab biosimilar Uzpruvo
FDA approves first interchangeable ustekinumab biosimilar Wezlana
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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 Nov 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-four-ustekinumab-biosimilars-eksunbi-fymskina-otulfi-steqeyma
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/biosimilars/news/fda-approves-biosimilars-ustekinumab-otulfi-and-eculizumab-epysqli
4. GaBI Online - Generics and Biosimilars Initiative. EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves third ustekinumab biosimilar Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-ustekinumab-biosimilar-pyzchiva
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