EC approval for trastuzumab biosimilar Ontruzant

Biosimilars/News | Posted 01/12/2017 post-comment0 Post your comment

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20 November 2017 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Ontruzant (SB3).

Breast cancer V15J22

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 approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 15 September 2017 [1].

Ontruzant is the first trastuzumab biosimilar to be approved in Europe. It has been approved for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer

The approval marks the fourth biosimilar approved in Europe for Samsung Bioepis. The company has also received approval for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab) [2].

Ontruzant will be commercialized in the EU by Merck Sharp and Dohme (MSD), which is known as Merck in the US and Canada.

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1. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars approved in South Korea []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from:

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Source: Samsung Bioepis

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