Trastuzumab biosimilar Herzuma approved in Canada

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Trastuzumab biosimilar Herzuma approved in Canada

Biosimilares/Novedades | Posted 20/09/2019 0 Post your comment

South Korean biotechnology company Celltrion announced on 10 September 2019 that Health Canada had approved its trastuzumab biosimilar Herzuma.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Herzuma is a biosimilar of Roche’s Herceptin (trastuzumab). Celltrion Healthcare, which is in charge of overseas distribution and marketing of Celltrion’s drugs, plans to discuss the launch period with Teva Pharmaceutical Industries (Teva), its partner for Herzuma’s distribution in North America.

Health Canada approved Herzuma based on comprehensive data from non-clinical and clinical trials, which, according to Celltrion, demonstrated that the safety and efficacy of Herzuma for treating breast and gastric cancer were comparable to the originator biological, Herceptin.

The Canadian regulator approved its first trastuzumab biosimilar, Mylan and Biocon’s Ogivri, in May 2019 [1].

Herzuma is the third of Celltrion’s biosimilars to be approved in Canada. Non-Hodgkin’s lymphoma treatment Truxima (rituximab) was approved in April 2019 [2], and Remsima (infliximab) was approved in 2014 for ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and rheumatoid arthritis [3]. This approval was extended to cover three extra indications: Crohn’s disease, fistulising Crohn’s disease and ulcerative colitis in June 2016 [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar Ogivri approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 20]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-Ogivri-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar Truxima approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 20]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-Truxima-approved-in-Canada
3. GaBI Online - Generics and Biosimilars Initiative. Infliximab SEB launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 20]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-SEB-launched-in-Canada
4. GaBI Online - Generics and Biosimilars Initiative. Health Canada approves Inflectra biosimilar for extra indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 20]. Available from: www.gabionline.net/Biosimilars/News/Health-Canada-approves-Inflectra-biosimilar-for-extra-indications

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Source: Korea Biomedical Review, Pulse News, The Investor