EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma

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EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma

Biosimilars/News | Posted 10/09/2024 0 Post your comment

On 25 July and 27 June 2024, 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 four ustekinumab biosimilars.

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 four ustekinumab biosimilar approved are: Eksunbi, Fymskina, Otulfi and Steqeyma. All are a biosimilar of Johnson & Johnson’s originator Stelara. The patents for Stelara expired in the US in September 2023 and in Europe in January 2024 [2].

Steqeyma was approved in June 2024, and Eksunbi, Fymskina and Otulfi were approved in July 2024. Table 1 presents the therapeutic areas of the four ustekinumab biosimilars and their respective applicants.

Table 1: EMA-approved ustekinumab biosimilars (June–July 2024)
Product name	Therapeutic area	Applicant
Eksunbi	Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis	Samsung Bioepis
Fymskina	Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis Ulcerative colitis	Formycon AG
Otulfi	Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis	Fresenius Kabi
Steqeyma	Crohn’s disease Paediatric plaque psoriasis Plaque psoriasis Psoriatic arthritis	Celltrion
EMA: European Medicines Agency.

Eksunbi, Fymskina, Otulfi and Steqeyma are ustekinumab biosimilars intended for the treatment of adults and children with plaque psoriasis, and adults with psoriatic arthritis, Crohn’s disease, or in the case of Eksunbi and Fymskina, ulcerative colitis.

These four newly approved ustekinumab biosimilars will be available in 45 mg or 90 mg for injection in pre-filled syringe and a 130 mg concentrate for solution for infusion.

Europe has already approved three ustekinumab biosimilars. The first, Uzpruvo, was approved on 9 November 2023 [3, 4], followed by Pyzchiva [5] and Wezenla [6], which received approval on 22 February and 25 April 2024, respectively. Each of these biosimilars has also been approved by the European Commission (EC). Steqeyma is the most recent ustekinumab biosimilar to receive EC approval on 26 August 2024.

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 Sep 10]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
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. EMA recommends approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 10]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-ustekinumab-biosimilar-uzpruvo
4. GaBI Online - Generics and Biosimilars Initiative. EC approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 10]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-first-ustekinumab-biosimilar-uzpruvo
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of ustekinumab biosimilar Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 10]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-ustekinumab-biosimilar-pyzchiva
6. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of biosimilar tocilizumab Tofidence and ustekinumab Wezenla [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 10]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-biosimilar-tocilizumab-tofidence-and-ustekinumab-wezenla

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