Trastuzumab biosimilar launched in South Korea

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Trastuzumab biosimilar launched in South Korea

Biosimilars/News | Posted 09/03/2018 0 Post your comment

South Korean pharmaceutical company Daewoong Pharmaceutical announced on 5 March 2018 that it had launched trastuzumab biosimilar Samfenet, developed by Samsung Bioepis, in South Korea.

Samfenet is a biosimilar of Roche’s blockbuster breast cancer treatment Herceptin (trastuzumab). Herceptin is a human epidermal growth factor receptor 2 positive (HER2+) breast cancer therapy designed to treat aggressive HER2+ metastatic and adjuvant breast cancer, as well as HER2+ adenocarcinoma of the stomach that has spread (metastatic or advanced gastric cancer).

Samsung Bioepis received marketing approval for Samfenet (SB3) from South Korea’s Ministry of Food and Drug Safety (MFDS) in November 2017 [1]. The approval of Samfenet in Korea represents the first biosimilar for use in oncology for Samsung Bioepis.

Samfenet is priced at a 29.5% discount to Herceptin, which had global sales of around US$6.5 billion in 2017.

Samfenet is not the first trastuzumab biosimilar on the South Korean market. In September 2017, Celltrion launched Herzuma (trastuzumab), after it gained MFDS approval in January 2014 [2].

Samsung Bioepis also submitted their proposed trastuzumab (SB3) to the US Food and Drug Administration for approval in December 2017 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 9]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-approved-in-South-Korea
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 9]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars

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Source: The Korea Herald