또한 “덴마크는 유럽 내 비교적 작은 시장이지만 타 국가에 비해 바이오시밀러 처방율이 가장 빠르게 증가하고 있는 곳이다”며 베네팔리의 판매 전망에 대해 긍정적인 의견을 표했다.
향후 베네팔리는 삼성바이오에피스의 유럽 마케팅 및 판매 협력사인 바이오젠을 통해 덴마크에서 판매될 예정이다. 현지 판매가격은 현재 공개 되지 않았지만 통상 바이오시밀러는 오리지널 약제 대비 약 40-50% 할인된 가격에 판매된다.
베네팔리는 미국의 글로벌제약사인 암젠이 개발한 바이오 의약품 ‘엔브렐’과 효능이 동일한 복제약이다. 엔브렐은 2014년 기준 전 세계적으로 89억달러 (약 10조 2000억원), 유럽에서만 25억달러 (약 2조 9000억원)의 매출을 올린 세계 2위 바이오 의약품이다.
지난해 2월 엔브렐의 유럽 특허가 만료되며 해당 국가에서 바이오시밀러 판매가 가능해졌다.
덴마크는 베네팔리가 진입하는 유럽 내 다섯 번째 시장이다. 삼성바이오에피스는 올해 1월 17일 유럽연합집행위원회(EC)로부터 ‘베네팔리’의 최종 판매허가를 받은 후 노르웨이, 독일, 영국, 네덜란드에서 본격 판매에 돌입했다. 본 약은 지난해 12월 ‘브렌시스’라는 이름으로 국내에 최초 출시되었다.
<관련 영문 기사>
Samsung's Enbrel biosimilar wins supply deal in Denmark
Samsung Bioepis’ Enbrel biosimilar won a supply deal from Denmark’s drug procurement agency Amgros on Tuesday, becoming the priority etanercept drug used for treating rheumatoid arthritis in the country, an industry source told The Korea Herald on condition of anonymity.
Benepali, Samsung’s biosimilar version of Amgen’s top-selling Enbrel, is expected to take away at least 50 percent of the original drug’s market share in Denmark, as local hospitals and doctors favor prescribing drugs selected by the procurement agency, he said.
Denmark, though a relatively small market in Europe, has one of the quickest expanding biosimilar usage rates in the world, the official said, projecting a steady sales outlook for Benepali.
Denmark is now the fifth European country in which Benepali is being sold, Samsung Bioepis confirmed to The Korea Herald. The drug obtained endorsement of state-run agencies in Norway, Germany, the U.K. and Netherlands earlier this year.
Biosimilars refer to an emerging category of cheaper, near replicas of complex, biologic drugs which have lost patent protection. Enbrel lost its exclusive patent in Europe in February 2015, opening the doors to biosimilar competition.
Samsung’s Benepali was approved by the European Commission on Jan. 17, becoming the first Enbrel biosimilar to enter the European market. Enbrel’s net sales in Europe reached about $2.5 billion in 2014.
Denmark’s pricing of Benepali has yet to be disclosed. However, biosimilars are typically priced 40-50 percent cheaper than the original drugs. U.S. pharmaceutical company Biogen is Samsung’s marketing and sales partner in Europe, including in Denmark.
"We have already launched Benepali in the UK, Norway, Germany, and Netherlands. With EMA approval of Benepali earlier this year, we expect to launch it in other EU countries this year," Biogen told The Korea Herald in a statement.
Samsung Bioepis is the biopharma affiliate of Korean electronics giant Samsung Group. The group holds high hopes for its biosimilars business led by Bioepis, as a promising field to lead the conglomerate’s future growth.
The IMS Institute for Healthcare Informatics predicts biosimilars will save as much as $110 billion for health systems in Europe and the U.S. by 2020.
Bioepis has set a target revenue of 1 trillion won ($872 million) by 2020, which hinges on the successful commercialization of its biosimilars in the U.S. and Europe, the world’s top two biopharmaceuticals markets.
Established in 2012, Samsung Bioepis is working on a pipeline of 13 biosimilar candidates. Its Enbrel biosimilar is now sold in the four European countries as well as in Korea.
ts Remicade (infliximab) biosimilar received a positive approval recommendation from the European Medicines Agency earlier this month.
By Sohn Ji-young(
jys@heraldcorp.com)
