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Biosimilar etanercept Eucept approved in South Korea Posted 11/05/2018

South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar 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.

South Korea’s drug regulator, the Ministry of Food and Drug Safety (MFDS), granted marketing approval for LG Chem’s Eucept (etanercept) on 17 March 2018.

The originator product, Amgen/Pfizer’s Enbrel (etanercept), had sales of US$8.8 billion in 2015, before the advent of biosimilars [1]. The patents on Enbrel will expire in the US in November 2028, after Amgen was granted a new patent, and expired in Europe in August 2015 [2, 3].

Eucept is the third etanercept biosimilar to receive regulatory approval in South Korea. Hanwha Chemical’s Davictrel received approval from the MFDS in November 2014, and Brenzys, produced by Merck/Samsung Bioepis, received approval in September 2015 [4].

Eucept is the first of LG Chem’s biosimilars to be approved. The company has also made a deal with Japan-based Mochida Pharmaceutical to co-develop and commercialize an adalimumab biosimilar (LBAL) for the Japanese market [5].

LG Chem is hoping that its new design, incorporating a slimmer injection needle, will prove a hit with patients, making the injection procedure more comfortable and less painful compared to its competitors.

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References
1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-etanercept
2.  Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
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 2018 May 11]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
4.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
5.   GaBI Online - Generics and Biosimilars Initiative. LG Life Sciences and Mochida make deal for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 11]. Available from: www.gabionline.net/Biosimilars/News/LG-Life-Sciences-and-Mochida-make-deal-for-adalimumab-biosimilar

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Source: The Korea Herald

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