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 cancers.

Celltrion’s biosimilar version of the drug, Herzuma, has been a success around the world, with approvals in major markets including the US [1] and Canada [2].

The biosimilar has also been approved in Japan, originally for the treatment of gastric cancer. In August 2019, the Japanese Ministry of Health, Labour and Welfare extended approval for the treatment of breast cancer. Herzuma was approved for use in a three-week cycle method, which is used in over 90% of breast cancer cases in Japan [3].

Despite there being two other trastuzumab biosimilars available in the Japanese market, Celltrion have announced gaining 40% market share with Herzuma. The market is worth US$324 million in total.

Local subsidiary Nippon Kayaku are responsible for the supply of Herzuma in Japan. The sales strategy uses differentiated marketing, with Nippon Kayaku targeting the supply chain while Celltrion focuses on individual hospitals.

A Celltrion official explained: ‘We tightened the sales network and operation with Nippon Kayaku, our local partner with experiences and know-how, managing the major supply networks, while Celltrion is taking care of marketing and sales activity for individual clinics’.

It is likely that Herzuma will continue to expand in the Japanese market as the government there has released a diagnosis-related group (DRG) system through which patients are grouped together for health insurance billing. This is likely to benefit biosimilars manufacturers, together with a revised doctor fee system which may increase biosimilar prescriptions.

A second South Korean biosimilar manufacturer, Samsung Bioepis, has announced good news recently. The company announced in April that sales of three of their biosimilar products – Benepali, Flixabi and Imraldi – reached sales of over US$200 million in Europe in the first quarter of 2020.

Between January and March 2020, the combined sales of the three biosimilars came to US$219 million, which is a 25% increase from the same period in 2019.

Samsung Bioepis, which is a joint venture between Samsung Biologics and Biogen, said sales of Benepali (etanercept) reached US$133.5 million (an 8% increase from 2019).

Although sales of Flixabi (infliximab) were less (of US$23.7 million), the increase in sales from 2019 is a significant 61%. Sales of Imraldi (adalimumab) increased even further, by 73%, to US$61.6 million. All three biosimilars are monoclonal antibody treatments for autoimmune disorders.

Samsung Bioepis also sells a trastuzumab biosimilar in Europe (Ontruzant). However, data are not available for Ontuzant as it is marketed and distributed in Europe by MSD, which does not release revenues for individual products.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Celltrion/Teva launch trastuzumab biosimilar Herzuma in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-Teva-launch-trastuzumab-biosimilar-Herzuma-in-US
2. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar Herzuma approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-Herzuma-approved-in-Canada
3. GaBI Online - Generics and Biosimilars Initiative. Herzuma gains Japanese approval for three-week cycle method [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 29]. Available from: www.gabionline.net/Biosimilars/News/Herzuma-gains-Japanese-approval-for-three-week-cycle-method

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