Benepali was developed by Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen. The drug is a biosimilar of Amgen/Pfizer’s Enbrel (etanercept). Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine.

Benepali received marketing authorization in the European Union on 14 January 2016, after having received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2015 [1].

According to Samsung Bioepis, Benepali will be sold at a 47% discount compared to the price of Enbrel in Norway via Samsung’s European partner, Biogen. In response, Pfizer is reportedly aggressively discounting Enbrel in order to try and maintain its market share in Norway.

Benepali is the first etanercept biosimilar to be approved in Europe, where sales of Enbrel, supplied by Pfizer, are reported to be US$2.5 billion. In Norway alone, sales are reported to be US$58 million.

Benepali may not be the only etanercept biosimilar in Europe for long. Sandoz, the generics division of Novartis, submitted an application for its proposed etanercept biosimilar (GP2015) to EMA in December 2015 [2].

Related article
Biosimilars of etanercept

References
1.  GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 5]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar  
2.  GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 5]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar  

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