Home / Biosimilars / News / Herzuma gains Japanese approval for three-week cycle method

Herzuma gains Japanese approval for three-week cycle method Posted 13/09/2019

South Korean biotechnology company Celltrion announced at the end of August 2019 that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved a three-week cycle method for its trastuzumab biosimilar, Herzuma (CT P6), in the treatment of breast cancer.

Herzuma is a biosimilar of Roche’s blockbuster breast cancer drug Herceptin (trastuzumab). 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 and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Celltrion’s distribution partner, Japan-based Nippon Kayaku, originally received approval for Herzuma from the MHLW in March 2018, but not in all indications of the reference product. The biosimilar was only approved for the treatment of HER2+ gastric cancers, and not for the treatment of HER2+ breast cancer. However, on 5 November 2018, the company announced that it had won a patent suit invalidating Roche’s patent on the originator product, Herceptin (trastuzumab) [1]. The company then received approval for the one-week cycle method for treatment of breast cancer from the MHLW later the same month.

Treatment of breast cancer with trastuzumab can be carried out using two methods – a one-week cycle method (52 doses) and a three-week cycle (18 doses). The three-week cycle method is used in more than 90% of breast cancer patients receiving trastuzumab in Japan. This fact, along with Japan’s rapidly ageing population and the fact that Japan is applying the diagnosis procedure combination (DPC)# system for breast cancer is expected to expand the use of Herzuma in the country, according to Celltrion.

#The diagnosis procedure combination (DPC) is a uniquely Japanese payment system that first emerged in the early 2000s amidst growing concerns over healthcare costs, length of hospital stays and the healthcare needs associated with the growing ageing population. The goal of the DPC is to support improvement in healthcare standards and transparency, as well as to reduce costs.

Related articles
Korean firms to launch biosimilars in Japan despite trade tensions

Japanese approval for Lupin’s etanercept biosimilar

Biosimilars of trastuzumab

1. GaBI Online - Generics and Biosimilars Initiative. Celltrion wins patent suit in Japan over trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 13]. Available from: www.gabionline.net/Biosimilars/General/Celltrion-wins-patent-suit-in-Japan-over-trastuzumab-biosimilar

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

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 .