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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.

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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

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Source: Korea Biomedical Review

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