Samsung Bioepis’ biosimilar hits $100 mil. sales in Europe

Samsung Bioepis' biosimilar hits $100 mil. sales in Europe

By Yoon Sung-won

Samsung Bioepis is accelerating business in Europe on solid sales of its first biosimilar medicine “Benepali,” according to the pharmaceutical industry Tuesday.

In its recent regulatory filing, U.S. pharmaceutical enterprise Biogen said it posted $100.6 million in sales of Benepali in the European market last year. In the first three quarters of 2016, cumulative sales from Benepali remained at $47.9 million.

But the number has skyrocketed to over $50 million in the fourth quarter alone, according to Biogen. As one of Samsung Bioepis’ shareholders with a 6.7 percent stake, Biogen is distributing the Korean company’s biosimilar medicines in Europe. Samsung BioLogics holds 93.3 percent stake of Samsung Bioepis as of the end of last year.

“Benepali is showing solid growth in Europe,” Biogen said.

Samsung Bioepis expected that the better-than-expected sales performance of its biosimilar products will help it turn to a profit. The company posted 100.2 billion won in operating losses in 2016, compared to the previous year’s 161.1 billion won deficit. Its annual sales reached 147.5 billion won last year.

“(Benepali) is showing faster sales growth as time goes on,” a Samsung Bioepis official said. “We expect that our financial status will improve following sales expansion.”

The biosimilar business affiliate of Samsung Group has developed Benepali based on the multinational pharmaceutical firm Amgen’s rheumatoid arthritis medicine named “Enbrel.” Enbrel brought in about $2.5 billion in Europe in 2014.

In January 2016, Samsung Bioepis acquired approval from the European Medicine Agency (EMA) to release Benepali in the region. It was the first time for an Enbrel copycat to be cleared for sale in Europe. The biosimilar has since been distributed not only in Korea but also in Europe.

Based on the rapid growth in Europe, Samsung Bioepis and Biogen plan to speed up penetration into the region, by expanding distribution networks of Benepali to Eastern Europe.

Biogen also aims to boost sale of another biosimilar “Flixabi” in the market. Flixabi has been developed by Samsung Bioepis based on Janssen Pharmaceutical’s autoimmune disease medicine “Remicade,” which is also known as “Infliximab.”

Flixabi was cleared to be sold in Europe in May last year and has been released in the region since the third quarter last year. But the sales from Flixabi have settled at about $100,000.

Biogen has recently signed an agreement with the Swiss-based medicine distributor Ewopharma to sell Benepali and Flixabi in six EU member nations including Romania, Croatia, Bulgaria, Estonia, Latvia and Lithuania.

Established as a joint venture of Samsung BioLogics and Biogen in 2012, Samsung Bioepis has also worked with chemical industry giant Merck to develop biosmilar medicines based on AbbVie’s rheumatoid arthritis medicine “Humira” and Roche’s breast cancer medicine “Herceptin.” In 2013, the two companies have agreed that Merck can distribute Benepali globally except for in the United States, Japan and the European Union.

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