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삼성바이오에피스가 개발한 첫 번째 바이오 복제약(바이오시밀러)이 처음으로 해외 시장에 공식 진출한다.
관련 업계에 따르면 지난 29일 삼성바이오에피스의 류머티스관절염 등 자가 면역 질환 치료제인 ‘베네팔리’가 노르웨이 의약품 국가 입찰(LIS)에서 TNF-알파억제제 부문의 대표 의약품으로 선정 되었다.
이는 ‘베네팔리’가 지난 17일 유럽에서 첫 공식 판매허가를 받은 지 약 2주만에 달성한 쾌거로서 삼성이 2012년부터 개발에 돌입한 바이오시밀러 의약품의 본격 상업화의 시작을 알린다는 점에서 의미가 크다.
관련 업계에 따르면 지난 29일 삼성바이오에피스의 류머티스관절염 등 자가 면역 질환 치료제인 ‘베네팔리’가 노르웨이 의약품 국가 입찰(LIS)에서 TNF-알파억제제 부문의 대표 의약품으로 선정 되었다.
이는 ‘베네팔리’가 지난 17일 유럽에서 첫 공식 판매허가를 받은 지 약 2주만에 달성한 쾌거로서 삼성이 2012년부터 개발에 돌입한 바이오시밀러 의약품의 본격 상업화의 시작을 알린다는 점에서 의미가 크다.
‘베네팔리’는 미국의 글로벌제약사인 암젠이 개발한 바이오 의약품 ‘엔브렐’의 바이오 복제약이다. 지난해 ‘엔브렐’의 유럽 특허가 만료되며 해당 국가에서 바이오시밀러 판매가 가능해졌다.
노르웨이 보건당국에 따르면 ‘베네팔리’는 삼성바이오에피스의 유럽 마케팅 협력사인 바이오젠을 통해 오리지널 약제 대비 약 47% 할인된 가격에 노르웨이에서 이르면 2월부터 공식 판매될 예정이다.
업계에서는 국가 입찰에서 선정된 의약품은 해당 지역의 국립 병원 및 약국에서 활발히 판매되는 만큼 ‘베네팔리’ 역시 앞으로 노르웨이에서 높은 처방률을 달성할 것으로 보고 있다.
또한 ‘베네팔리’의 노르웨이 판매가 본격 시작되며 오리지널 엔브렐과 바이오시밀러 간의 치열한 경쟁이 시작될 것으로 예상된다. 현재 엔브렐의 유럽 마케팅은 미국 대형 제약사 화이자가 맡고 있다.
앞으로 타 유럽연합 국가들에서도 ‘베네팔리’의 판매가 본격 개시되면서 두 사의 판매경쟁은 한층 더 극대화 될 것으로 보인다.
외신에 따르면 현재 화이자는 노르웨이에서 판매되는 엔브렐의 가격을 대폭 낮추어 상대적으로 저렴한 바이오시밀러 의약품의 시장진출에 강력히 대응할 예정이라고 알려졌다.
또한 지난 12월 노바티스의 자회사인 산도스는 자사가 개발한 엔브렐 바이오시밀러의 유럽 허가 신청을 완료했다.
엔브렐의 전체 유럽 시장 규모는 약 25억 달러로 추정된다. 이 중 노르웨이가 차지하는 부문은 약 5천8백만 달러이다.
코리아헤럴드 손지영 기자 (jys@heraldcorp.com)
<관련 영문 기사>
Samsung’s Enbrel biosimilar wins first overseas contract
Samsung Bioepis has won its first overseas bid to supply its copy of the blockbuster arthritis treatment Enbrel in Norway, paving the way for its push to challenge global phamaceutical giants in the nascent but lucrative market for biosimilar drugs.
The development comes just two weeks after the European Commission’s approval of Benepali, Samsung’s biosimilar replication of Amgen’s top-selling drug Enbrel, known scientifically as etanercept, on Jan. 17.
According to industry sources, Norway’s medicines agency confirmed Friday that Benepali will be sold at a 47 percent cheaper price compared to original Enbrel in Norway through Samsung’s European marketing partner Biogen.
Benepali is expected to be purchased by most of the country’s state-run hospitals and pharmacies, as has been the case with drugs selected by Norway’s Drug Procurement Cooperation agency.
“The Norwegian launch is a big boost for Benepali,” said a source close to the matter on condition of anonymity. “It would pose a direct threat to the sales of Enbrel in the country and other European markets in the future.”
Samsung’s Benepali is the first Enbrel biosimilar to be approved in Europe, where sales of Enbrel, marketed by Pfizer, total about $2.5 billion. In Norway alone, its sales are estimated at $58 million.
Despite the pending European approval of another Enbrel biosimilar, developed by Norvartis affiliate Sandoz, Samsung Bioepis and Biogen are expected to secure a competitive edge as the first comer in the segment, the source added.
At the same time, Pfizer has reportedly decided to offer heavy discounts on its original drug to defend its market share, signaling the beginning of a fierce competition between original and biosimilar drug developers in Norway.
Biosimilars refer to lower-cost copies of brand-name biologic treatments that have lost their patent protection. A number of companies around the world, including Samsung, have jumped into this newly emerging segment, seeking high growth potential and profits.
Citigroup analyst Andrew Baum predicted last year that, “(Original drug developers) will likely lose an aggregate $360 billion in revenue over the next 10 years, with roughly $110 billion captured by biosimilar sponsors,” generating about $50 billion in savings for health care systems.
By Sohn Ji-young (jys@heraldcorp.com)
Samsung’s Enbrel biosimilar wins first overseas contract
Samsung Bioepis has won its first overseas bid to supply its copy of the blockbuster arthritis treatment Enbrel in Norway, paving the way for its push to challenge global phamaceutical giants in the nascent but lucrative market for biosimilar drugs.
The development comes just two weeks after the European Commission’s approval of Benepali, Samsung’s biosimilar replication of Amgen’s top-selling drug Enbrel, known scientifically as etanercept, on Jan. 17.
According to industry sources, Norway’s medicines agency confirmed Friday that Benepali will be sold at a 47 percent cheaper price compared to original Enbrel in Norway through Samsung’s European marketing partner Biogen.
Benepali is expected to be purchased by most of the country’s state-run hospitals and pharmacies, as has been the case with drugs selected by Norway’s Drug Procurement Cooperation agency.
“The Norwegian launch is a big boost for Benepali,” said a source close to the matter on condition of anonymity. “It would pose a direct threat to the sales of Enbrel in the country and other European markets in the future.”
Samsung’s Benepali is the first Enbrel biosimilar to be approved in Europe, where sales of Enbrel, marketed by Pfizer, total about $2.5 billion. In Norway alone, its sales are estimated at $58 million.
Despite the pending European approval of another Enbrel biosimilar, developed by Norvartis affiliate Sandoz, Samsung Bioepis and Biogen are expected to secure a competitive edge as the first comer in the segment, the source added.
At the same time, Pfizer has reportedly decided to offer heavy discounts on its original drug to defend its market share, signaling the beginning of a fierce competition between original and biosimilar drug developers in Norway.
Biosimilars refer to lower-cost copies of brand-name biologic treatments that have lost their patent protection. A number of companies around the world, including Samsung, have jumped into this newly emerging segment, seeking high growth potential and profits.
Citigroup analyst Andrew Baum predicted last year that, “(Original drug developers) will likely lose an aggregate $360 billion in revenue over the next 10 years, with roughly $110 billion captured by biosimilar sponsors,” generating about $50 billion in savings for health care systems.
By Sohn Ji-young (jys@heraldcorp.com)
