EMA recommends approval of biosimilar tocilizumab Tofidence and ustekinumab Wezenla

Biosimilars/News | Posted 05/06/2024 post-comment0 Post your comment

On 25 April 2024, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilar medicines: Tofidence (tocilizumab) and Wezenla (ustekinumab), recommending the granting of marketing authorization. This comes following news that Wezlana reached the market in Canada in early March 2024.

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Tofidence (tocilizumab)
Tofidence (tocilizumab) is a biosimilar of Roche’s Actemra (tocilizumab).  Tofidence was developed by Biogen and is approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and coronavirus disease 2019 (COVID-19).

Tocilizumab is a humanized monoclonal antibody which acts against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis [1].

Tofidence has received EMA approval for both subcutaneous and intravenous formulations. It will be available as a 20 mg/ml concentrate for solution for infusion.

Tofidence (tocilizumab-bavi) is the first biosimilar tocilizumab to gain approval in the US, which was granted in October 2023 [2]. 

Tofidence will become the second tocilizumab biosimilar available in Europe, following Fresenius Kabi’s Tyenne, which received EC approval on 15 September 2023 [3].

Wezenla (ustekinumab)
Wezenla (ustekinumab) is a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Wezenla was developed by Amgen and is approved for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease. 

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].

Wezenla will be available as 45 and 90 mg solution for injection and 130 mg concentrate for solution for infusion.

Amgen’s biosimilar ustekinumab is called Wezenla in Europe and Wezlana in Canada [5] and the US [6].

Wezlana was the first approved biosimilar of Stelara in the US, where it has the interchangeability designation [6]. It is also one of the first 10 drugs to be selected as part of Medicare drug price negotiation program, which seeks to reduce biosimilars prices as part of the Inflation Reduction act [7]. 

Related article
EMA recommends approval of ustekinumab biosimilar Pyzchiva

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence
3. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
5. GaBI Online - Generics and Biosimilars Initiative. Three more biosimilar approvals in Canada in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/biosimilars/news/three-more-biosimilar-approvals-in-canada-in-2023
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
7. GaBI Online - Generics and Biosimilars Initiative. Four drugmakers sue the US government over the Inflation Reduction Act [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 5]. Available from: www.gabionline.net/pharma-news/four-drugmakers-sue-the-us-government-over-the-inflation-reduction-act

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