The company announced on 12 April 2017 that it had filed for approval of Herzuma (CT-P6), its biosimilar trastuzumab monoclonal antibody, with Japan’s Ministry of Health, Labour and Welfare (MHLW). This is Celltrion’s second submission in Japan. The company’s biosimilar infliximab Remsima (CT-P13) is already approved in the country [1] and it also submitted an application for approval to the European Medicines Agency (EMA) in November 2016 [2]. Furthermore, the company is challenging patents on Genentech’s Herceptin in the US with a view to filing for approval of its trastuzumab biosimilar (Herzuma) in the US.

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.

The originator product, Roche’s (Genentech) Herceptin (trastuzumab), had 2016 worldwide sales of CHF 6.8 billion (US$6.7 billion). The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [3].

Celltrion has also received approval from China’s Food and Drug Administration (CFDA) to start clinical trials for its infliximab biosimilar, Remsima (CT-P13), in the country. This will make it the first foreign company to initiate clinical trials of an antibody biosimilar in China. Remsima was approved by EMA in September 2013 [4] and Celltrion’s partner, Hospira (Pfizer), received US Food and Drug Administration (FDA) approval for Inflectra (infliximab-dyyb) in April 2016 [5].

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

The originator product, Johnson & Johnson and Merck’s Remicade (infliximab), had worldwide sales of US$9.3 billion in 2014, before the advent of biosimilars. The patents on Remicade will expire in the US in September 2018 and expired in Europe in February 2015 [3].

Celltrion is also planning to seek CFDA’s approval to test two additional biosimilar candidates, Truxima (rituximab) and Herzuma, during 2017.

Related articles
Biosimilars of infliximab

Biosimilars of trastuzumab

Celltrion starts phase III biosimilar trastuzumab trial

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-infliximab
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits trastuzumab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-trastuzumab-biosimilar-application-to-EMA
3. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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