Adalimumab and trastuzumab biosimilars approved in South Korea Posted 17/11/2017

South Korean biosimilars maker Samsung Bioepis announced on 9 November 2017 that it had received marketing approval for its biosimilar version of Roche’s blockbuster breast cancer therapy Herceptin (trastuzumab) from Korea’s Ministry of Food and Drug Safety (MFDS). The news follows another announcement by the company on 22 September 2017 that it had also gained approval for its adalimumab biosimilar (SB5).

The approval of the adalimumab biosimilar, Hadlima (SB5), marks the third Korean biosimilar approval for Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen Idec.

The originator adalimumab product AbbVie’s Humira had worldwide sales of US$16.1 billion in 2016. However, Samsung Bioepis will have to wait until the Korean patent on Humira expires in January 2019 before it can start to sell its adalimumab treatment in the country.

The approval of the trastuzumab biosimilar, Samfenet (SB3), in Korea represents the first biosimilar for use in oncology for Samsung Bioepis. The company has not yet decided on an exact timetable for the release in South Korea or on who will be its domestic distribution partner.

The originator trastuzumab product, Roche’s Herceptin had 2016 worldwide sales of CHF 6.8 billion (US$6.7 billion) [1] making it the world’s eighth top-selling drug and a lucrative target for biosimilars developers. 2016 sales of Herceptin in South Korea amounted to more than US$89.70 million.

Korea’s MFDS has already approved seven other biosimilars for use in the country, including etanercept (2), infliximab (2), rituximab (1), trastuzumab (1) and somatropin (1) biosimilars. Samsung Bioepis already markets two biosimilars in South Korea, Brenzys (etanercept) and Renflexis (infliximab) [2].

Samsung Bioepis gained European Medicines Agency (EMA) approval for its adalimumab biosimilar, which is called Imraldi in the European Union (EU), in June 2016 [3]. The company also gained EMA approval for its trastuzumab biosimilar (SB3), which is called Ontruzant in the EU, in September 2017 [4].

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Biosimilars approved in South Korea

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
3. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilar Imraldi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilar-Imraldi
4. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-and-trastuzumab-biosimilars

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Source: Korea Herald

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