On 11 October 2024, Health Canada approved Fresenius Kabi’s tocilizumab biosimilar, Tyenne – the first and only tocilizumab biosimilar currently available in Canada – which references Roche’s Actemra/RoActemra (tocilizumab).
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 [1].
Tyenne is indicated for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome and for the treatment of COVID-19.
Health Canada’s approval of Tyenne was based on pharmacokinetic similarity to Actemra, as demonstrated by two phase 1 similarity studies conducted in healthy subjects. In these studies, the 90% confidence intervals for the relative Cmax and AUClast were fully contained within Health Canada’s prespecified comparative pharmacokinetic biosimilarity margin of 80.0% to 125.0%.
The safety profile of Tyenne was consistent with that of Actemra in a phase 3 comparative clinical efficacy and safety study. Tyenne was well tolerated over 55 weeks and up to 63 weeks, with an incidence of adverse events generally consistent with those observed for Actemra. However, robust conclusions regarding Tyenne’s safety profile are limited by the relatively small number of patients included in the study.
Tyenne is available in the injections of 80 mg/4 mL, 162 mg/0.9 mL, 200 mg/10 mL, and 400 mg/20 mL.
Tyenne was also approved in Europe and the US on 19 September and 7 March 2024, respectively [2, 3]. The first tocilizumab biosimilar approved in Europe and the US was Biogen’s Tofidence, which received approval on 20 June 2024 and 29 September 2023, respectively [4, 5].
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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 Dec 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
2. 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 Dec 3]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/biosimilars/news/ec-approvals-of-four-biosimilars-tofidence-wezenla-avzivi-and-steqeyma
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence
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