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Biosimilar trastuzumab approved in Korea Posted 17/01/2014

South Korean biotechnology company Celltrion announced on 15 January 2014 that it had received approval for its biosimilar monoclonal antibody Herzuma (trastuzumab) with the Korean Ministry of Food and Drug Safety (MFDS, formerly Korea Food and Drug Administration).

Herzuma is a biosimilar of Roche’s blockbuster breast cancer treatment Herceptin (trastuzumab). Herceptin is a HER2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer, as well as HER2 positive adenocarcinoma of the stomach that has spread (metastatic or advanced gastric cancer). The biosimilar Herzuma has been approved for the same indications as Herceptin, i.e. treatment of ‘early and advanced (metastatic) HER2+ breast cancer as well as advanced (metastatic) stomach cancer’.

Celltrion gained European approval for its first monoclonal antibody biosimilar infliximab (Remsima/Inflectra) as part of its collaboration with US-based generics major Hospira [1]. Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3], and has also applied for approval in Japan [4].

The South Korean approval for Herzuma was based on data from global clinical trials in a total of 558 patients carried out between August 2009 and December 2011 at 115 sites in 18 countries, including sites in Europe.

Roche’s Herceptin generated global sales over US$6.3 billion in 2012 [5]. Celltrion estimates the Korean domestic market size to be approximately KRW 80 billion (approximately US$80 million) and expects to start marketing Herzuma in the first half of 2014. Good news for patients in Korea is that as soon as the first biosimilar product is introduced into the market the price of the original reference product will automatically drop to 70% of the original price.

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References

1.  GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 17]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar

2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea 

3.  GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 17]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia

4.  GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for biosimilar infliximab approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 17]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-biosimilar-infliximab-approval-in-Japan

5.  GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for Korean approval of biosimilar trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 17]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-Korean-approval-of-biosimilar-trastuzumab

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Source: Celltrion

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