Samsung Bioepis to launch infliximab biosimilar in South Korea

Biosimilares/Novedades | Posted 20/05/2016 post-comment0 Post your comment

Samsung Bioepis has completed the regulatory process to enable the launch of its second biosimilar Renflexis (infliximab) in South Korea.

23 AA011020

Samsung Bioepis received approval for Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) in December 2015 [1].

The South Korean drug manufacturer is expected to launch Renflexis in Korea at a price of Won 363,530 (US$315) per box. This reflects an approximate 5% discount compared to the originator product Johnson & Johnson and Merck’s Remicade (infliximab) and is about the same price as Celltrion’s biosimilar infliximab product, Remicade.

Renflexis was developed as part of a partnership between Merck and Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen. Merck will commercialize Renflexis in Korea, through its subsidiary MSD Korea, and as part of Merck’s commercialization partnership with Samsung Bioepis.

Renflexis will be launched in South Korea in June 2016, according to MSD Korea, which is responsible for the marketing and distribution of Renflexis. MSD Korea has already been marketing and distributing Brenzys, Samsung Bioepis and Merck’s etanercept biosimilar, since December 2015.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of the infliximab biosimilar from Samsung Bioepis on 1 April 2016. In Europe, the biosimilar will be called Flixabi (SB2) [2].

1. GaBI Online - Generics and Biosimilars Initiative. Korean approval for infliximab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 20]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 20]. Available from:

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Source: Korea Joongang Daily, MSD Korea, The Korea Herald

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