In August 2024, Henlius Biotech's trastuzumab biosimilar, Adheroza, received marketing approval from Health Canada. In July 2024, Celltrion’s ustekinumab biosimilar, Steqeyma (CT-P43), also gained Health Canada approval.
Adheroza (Henlius)
Shanghai Henlius Biotech (Henlius) announced on 22 August 2024 that its self-developed and manufactured trastuzumab biosimilar, Adheroza (HLX02), has received marketing approval (Notice of Compliance) from Health Canada.
In Canada, Adheroza has been approved for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
HLX02 trastuzumab is marketed under various tradenames in different regions: Hanquyou in China, Hercessi in the US [1], Zercepac in Europe [2], and Adheroza in Canada. Now approved in Canada, it will be marketed by Accord Healthcare.
Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (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 [3].
Henlius has the following antibody-based biosimilars approved in China from 2019 to the present: adalimumab, bevacizumab, rituximab, and trastuzumab.
Steqeyma (Celltrion)
Celltrion announced on 31 July 2024 that it had received New Drug Submission (NDS) approval from Health Canada for its ustekinumab biosimilar, Steqeyma (CT-P43). This follows the June 2024 approval from the South Korean Ministry of Food and Drug Safety and the subsequent positive opinion recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 27 June 2024 [4].
Steqeyma is a biosimilar referencing Jansen’s Stelara (ustekinumab).
The global market size for ustekinumab reached US$20.4 billion in 2023. The North American market, including Canada and the US, accounted for 80% of the global market (US$16.38 billion), making it the largest market for ustekinumab globally.
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 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 1]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 1]. Available from: www.gabionline.net/biosimilars/news/EC-approval-for-trastuzumab-biosimilar-Zercepac
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 1]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab
4. 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 Oct 1]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-four-ustekinumab-biosimilars-eksunbi-fymskina-otulfi-steqeyma
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 1]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
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