EC approval for trastuzumab biosimilar Herzuma

Biosimilars/News | Posted 02/03/2018 post-comment0 Post your comment

South Korean biotechnology company Celltrion announced on 14 February 2018 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Herzuma (CT‑P6).

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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 December 2017 [1].

Herzuma is an anticancer monoclonal antibody (mAb) biosimilar drug used to treat breast cancer and gastric cancer. According to Celltrion, the ‘similarity of Herzuma to the reference product, Herceptin, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials’. The company received approval for Herzuma from the Korean Ministry of Food and Drug Safety (MFDS, formerly Korea Food and Drug Administration) back in January 2014 [2] and launched the biosimilar in Korea in 2017.

Celltrion gained European approval for its first monoclonal antibody biosimilar, infliximab (Remsima/Inflectra), as part of its collaboration with US-based generics major Hospira [3]. Since then, the company has also gained EC approval for rituximab biosimilars Blitzima, Ritemvia, Rituzena (previously Tuxella) and Truxima [4].

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1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilars receive EMA and ANVISA approval []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 2]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 2]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 2]. Available from:

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Source: Celltrion

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