The drug in question is a biosimilar version of Amgen and Pfizer’s blockbuster rheumatoid arthritis drug Enbrel (etanercept).

Hanwha received approval for its biosimilar etanercept (HD203), which is called Davictrel, from the Korean Ministry of Food and Drug Safety (MFDS) on 11 November 2014.

Hanwha made a deal with German drug maker Merck KGaA (Merck Group) back in 2011 to develop and commercialize biosimilar etanercept. Under the terms of this 2011 agreement Merck KGaA will be responsible for manufacturing and commercializing HD203 globally, except for Korea and Turkey where Hanwha has retained marketing rights [1].

Merck KGaA has also made biosimilars deals with contract research organization Parexel [2] and Korean electronics giant Samsung’s specialized biologicals unit, Samsung Bioepis [3].

Enbrel, which is also used to treat psoriasis and ankylosing spondylitis, had worldwide sales of US$8.8 billion in 2013; making it one of the top selling biologicals and a lucrative target for biosimilars developers. The patents on Enbrel are set to expire in Europe in August 2015, but will only expire in the US in November 2028 after Amgen was granted a new patent [4, 5].

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Biosimilar etanercept demonstrates equivalent efficacy

References
1.   GaBI Online - Generics and Biosimilars Initiative. Merck enters biosimilars deal with Korea’s Hanwha [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 6]. Available from: www.gabionline.net/Biosimilars/News/Merck-enters-biosimilars-deal-with-Korea-s-Hanwha
2.   GaBI Online - Generics and Biosimilars Initiative. Merck and Parexel form strategic alliance for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 6]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Parexel-form-strategic-alliance-for-biosimilars 
3.   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 Feb 6]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin 
4.   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 Feb 6]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020 
5.   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 Feb 6]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028 

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