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Benepali wins Danish tender for etanercept Posted 13/05/2016

Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the priority drug for treating rheumatoid arthritis rather than the originator biological (Amgen’s Enbrel).

Amgros is the pharmaceutical procurement service for the five regional authorities in Denmark. Their main task is to ensure that public hospitals in Denmark have the medicines they need at the lowest prices. This they achieve through tenders and bulk purchasing. They are responsible for purchasing 99% of the medicines used by public hospitals in Denmark.

Although Denmark is a relatively small market in Europe, it has one of the quickest expanding biosimilar usage rates in the world. An industry source estimated that Benepali will capture at least 50% of the market share of Enbrel in the country due to the fact that local hospitals and doctors favour prescribing drugs selected by the procurement agency.

Samsung Bioepis is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen. Benepali will be sold in Denmark by Biogen, which is responsible for marketing Benepali in Europe. The pricing of Benepali in Denmark has yet to be disclosed. However, in February 2016 Biogen won a contract in Norway to supply Benepali at a 47% discount compared to the price of Enbrel in Norway [1].

The patents for Enbrel expired in Europe in August 2015 and will expire in the US in November 2028 [2].

Benepali gained European Commission approval in January 2016 and also obtained the endorsement of state-run agencies in Germany, The Netherlands, Norway and the UK at the beginning of 2016.

Benepali is the first etanercept biosimilar approved in Europe, where sales of Enbrel, supplied by Pfizer, are reported to be US$2.5 billion [1].  However, it 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 the European Medicines Agency in December 2015 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept offered at 47% discount in Norway [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-etanercept-offered-at-47-discount-in-Norway
2. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4): 177-8. doi:10.5639/gabij.2015.0404.040
3. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar

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Source: Amgros, The Korea Herald

Comments (1)

Benepali posted 13/05/2016 - by Jonas Gamrath Rasmussen, Dagens Medicin

In the latest Danish tender the pricing of Benepali was 51 percent below the list price of Enbrel. The tender runs from May through June and in July a new tender is expected to secure the Danish hospitals even more discount. The first tender ran in April and landed on a 42 percent discount compared to the list price of Enbrel. Best regards Jonas G. Rasmussen Journalist at Dagens Medicin in Denmark Twitter: @Gamrath

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