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, submitted an application for approval of Herzuma to Japan’s Ministry of Health, Labour and Welfare (MHLW) in April 2017 [1]. The product received approval from the MHLW in March 2018, but not in all indications of the reference product. It was only approved for the treatment of HER2+ gastric cancers, and not for the treatment of HER2+ breast cancer.

Celltrion has tried to invalidate Roche’s patent since 2016. After winning the two appeals trials for invalidation of the patent, the Korean company is now seeking approval for the additional indication of breast cancer for Herzuma.

Celltrion estimates the size of the market for the originator trastuzumab biological, Herceptin, in Japan to be around KRW 450 billion (Euros 349 billion).

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar submitted for approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-submitted-for-approval-in-Japan

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