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Korean approval for infliximab biosimilar Posted 11/12/2015

Samsung Bioepis and partner Merck announced on 4 December 2015 that Samsung Bioepis had received approval for its infliximab biosimilar Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. Renflexis has been approved in Korea for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis in adults (≥ 18 years).

Merck will commercialize Renflexis in Korea as part of Merck’s commercialization partnership with Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen. Merck plans to launch Renflexis in South Korea in the first half of 2016.

Merck and Samsung Bioepis made a deal to develop and commercialize biosimilars back in February 2013 [1]. This was expanded in February 2014 to include biosimilar insulin [2] and now covers infliximab, etanercept, adalimumab, trastuzumab and insulin glargine. The Korean MFDS approved Brenzys (etanercept), another biosimilar covered by the Merck/Samsung Bioepis partnership, on 8 September 2015 [3].

Celltrion was the first to gain European approval for infliximab (Remsima/Inflectra), as the world’s first monoclonal antibody biosimilar and as part of its collaboration with US-based generics major Hospira [4]. Samsung Bioepis submitted its biosimilar infliximab for European Medicines Agency’s (EMA) approval in March 2015 [5]. In November 2015, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the company’s biosimilar etanercept product (SB4) [6].

Related article
Biosimilars approved in South Korea

References
1.    GaBI Online - Generics and Biosimilars Initiative. Merck makes biosimilars deal with Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Merck-makes-biosimilars-deal-with-Samsung-Bioepis
2.    GaBI Online - Generics and Biosimilars Initiative. Merck and Samsung Bioepis collaborate on biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin
3.    GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-approved-in-South-Korea
4.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5.    GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis submits second biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-submits-second-biosimilar-to-EMA
6.         GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar

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Source: Merck, Samsung Bioepis

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