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Biosimilar etanercept approved in South Korea Posted 11/09/2015

US pharma giant Merck and South Korean biosimilars maker Samsung Bioepis announced on 8 September 2015 the approval of their biosimilar etanercept product Brenzys by the Ministry of Food and Drug Safety (MFDS) in Korea.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

The approval of Brenzys in Korea was supported by rigorous analytical structural and functional testing, as well as a phase I crossover pharmacokinetics study and a phase III clinical study comparing Brenzys to the originator medicine [1].

The approval of Brenzys in Korea represents the first product approval under Merck’s collaboration with Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen Idec. Merck plans to launch Brenzys in South Korea by the end of 2015 or early 2016.

The originator product, Amgen’s Enbrel (etanercept), had sales of US$4.7 billion in 2014, making it one of the top selling biologicals and a lucrative target for biosimilars developers. The patents on Enbrel expire in the US in November 2028, after Amgen was granted a new patent, and in Europe in August 2015 [2, 3].

Samsung Bioepis also announced in January 2015 that it had submitted its etanercept biosimilar candidate, SB4, to the European Medicines Agency for approval in the European Union [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for candidate etanercept and infliximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-candidate-etanercept-and-infliximab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
3. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept submitted for approval in EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-submitted-for-approval-in-EU

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Source: Merck, Samsung Bioepis

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