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.
Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
Biosimilars/News | Posted 01/10/2024 0 Post your comment
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].
Related articles
Unveiling key clinical findings for denosumab biosimilar candidates
Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US
LATIN AMERICAN FORUM View the latest headline article: Nuevos hallazgos de semaglutida en el tratamiento de la hidradenitis supurativa Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO Ver el último artículo de cabecera: Nuevos hallazgos de semaglutida en el tratamiento de la hidradenitis supurativa !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
Research
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
General
Ten best-selling biosimilars in Brazil in 2023
International biosimilars players expanding their presence in China
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Comments (0)
Post your comment