FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars

Biosimilares/Novedades | Posted 19/06/2024 post-comment0 Post your comment

In April 2024, the US Food and Drugs Administration (FDA) approved Alvotech and Teva’s Selarsdi (ustekinumab-aekn), a biosimilar to Stelara and Shanghai Henlius Biotech’s Herceptin biosimilar, Hercessi (trastuzumab-strf). This comes after the March 2024 news of the approval of Fresenius Kabi’s Tyenne (tocilizumab-aazg), the first tocilizumab biosimilar with an intravenous and subcutaneous formulation.

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Selarsdi
The Selarsdi (ustekinumab-aekn) injection for subcutaneous use is a biosimilar to Johnson & Johnson’s (J&J) Stelara. It has been approved for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and paediatric patients 6 years and older. 

This follows the news that Alvotech and Teva reached a settlement and license agreement with J&J, granting a license entry date for Selardsdi in the US no later than 21 February 2025 [1, 2].

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 [3].

Selarsdi is available in 45 mg/0.5 mL and 90 mg/mL injection.

Hercessi
Hercessi (trastuzumab-strf), Shanghai Henlius Biotech’s Herceptin biosimilar, has been approved for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  

Shanghai Henlius submitted an application to FDA in early 2023 [4]. The approval marks the sixth for a biosimilar referencing Roche’s Herceptin (trastuzumab) and first for Shanghai Henlius Biotech in the US.

Trastuzumab is a monoclonal antibody that binds to and inactivates the HER2/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers [5].

Hercessi is available in 150 mg injection.

Tyenne
Tyenne (tocilizumab-aazg), Fresenius Kabi’s tocilizumab biosimilar, is the first biosimilar of its kind to be approved in the US, referencing Roche’s Actemra/ RoActemra (tocilizumab). Fresenius Kabi submitted an application to FDA on 1 August 2022 [5]. The product has already been approved in Europe [6] and is Fresenius Kabi’s third biosimilar approved in the US.

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 systemic juvenile idiopathic arthritis, a severe form of arthritis in children [7].

Tyenne is approved for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  Tyenne is available in 80 mg/4mL, 162 mg/0.9 mL, 200 mg/10 mL, and 400 mg/20 mL injections. 

Although Tyenne is the first tocilizumab biosimilar with both intravenous and subcutaneous formulations, Bio-Thera Solutions/Biogen’s Tofidence, available only via intravenous infusion, was the first tocilizumab biosimilar to gain approval in the US in September 2023 [8].

Related article
FDA approves first interchangeable ustekinumab biosimilar Wezlana

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars lawsuits and settlement updates for Regeneron and Alvotech [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from:
www.gabionline.net/pharma-news/biosimilars-lawsuits-and-settlement-updates-for-regeneron-and-alvotech
2. GaBI Online - Generics and Biosimilars Initiative. J&J lawsuits settled over ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/pharma-news/j-j-lawsuits-settled-over-ustekinumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
4. GaBI Online - Generics and Biosimilars Initiative. Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/biosimilars/news/advances-for-henlius-trastuzumab-and-bevacizumab-biosimilars-in-the-us
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab
6. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for tocilizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-tocilizumab-biosimilar
7. 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 19]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
9. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 19]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence

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