Home / Biosimilars / News / Trastuzumab biosimilar Herzuma approved in Canada

Trastuzumab biosimilar Herzuma approved in Canada Posted 20/09/2019

20920796_l

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].

Related article
Biosimilars approved in Canada

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

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 © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Korea Biomedical Review, Pulse News, The Investor

Comments (1)

best cure posted 22/09/2019 - by mary johnson

ALL THANKS TO DR OSO WITH HIS HERBAL PORTION I WAS COMPLETELY CURED FROM BREAST CANCER.  I'm here again to appreciate. DR OSO God will always continue to bless you more abundantly, for the good works you don in my life, I will always keep on writing good and posting my testimonies about you on the Internet, I’m MARY JOHNSON from TEXAS . I was tested breast cancer positive, I saw a blog on how DR OSO cured people with his herbal portion, i did not believe in natural medicine but i just decided to give him a try, I contacted him,and explain my situation to him,few day later he sent me the herb, after taking DR OSO  herbal medicine for few weeks i went to hospital for check up so luckily i was healed  with his herbal portion, i am so happy. If you have any type of cancer problem or you are also infected with any kind of disease, contact him drosohaberhome@gmail.com or call/whatapp +2348162084839 for advice and for his product,i hope this testimony also help some one out there ..              here is the  dr website. https://sites.google.com/view/drosohaberhome/ His blog page https://drosohaberhome.blogspot.com you can also email me for more info about DR oso  via maryjohnson9700@gmail.com     ALL THANK TO DR OSO .