The application for approval of Celltrion’s trastuzumab biosimilar Herzuma (CT-P6) was submitted to EMA on 27 October 2016. The submission follows those by Biocon/Mylan and Samsung Bioepis, a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen. Both submitted marketing applications to EMA for trastuzumab biosimilars in August 2016 [1, 2].

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.

There is unfortunately no information as to what indications Celltrion is seeking approval. There is also no mention of what data were included in the submission. However, the company said that ‘after conducting multiple clinical trials on the efficacy of Herzuma on diverse breast cancer-related ailments, we have secured an advantage as a ‘first mover’ in the (Herceptin biosimilar segment)’.

The originator product, Roche’s Herceptin (trastuzumab) had sales of CHF 6.5 billion (US$6.6 billion) in 2015. The patents on Herceptin expire in the US in June 2019 and expired in Europe in July 2014 [3].

This marks Celltrion’s third marketing application in the European Union. Celltrion’s infliximab biosimilar (Remsima) was approved by EMA in September 2013 [4]. Then, it submitted a marketing application for its rituximab biosimilar CT-P10 to EMA in November 2015 [5]. The company also received approval for its infliximab biosimilar (CT-P13) in the US in April 2016, claiming it to be the first monoclonal antibody biosimilar approved in the US [6].

Celltrion plans to seek regulatory approval from the US Food and Drug Administration (FDA) to sell Herzuma in the US. The company told The Korea Herald that it completed phase I clinical trials for Herzuma in the US in early September 2016, but declined to further comment on its clinical trials timetable in the US.

Herzuma has been marketed in South Korea since 2014 after it was approved by the Korean Ministry of Drug and Food Safety in January 2014 [7].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA
2. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-trastuzumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits rituximab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-rituximab-biosimilar-application-to-EMA
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-infliximab-biosimilar-Inflectra
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea

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