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Yoon seeks rebound, taps 5-term lawmaker as chief of staff
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Medical standoff deepens as doctors reject new med school plan, talks
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[Herald Interview] Why Toss invited hackers to penetrate its system
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[Graphic News] 77% of young Koreans still financially dependent
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S. Korean envoys convene to navigate strategy amid Middle East tensions
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North Korea fires several short-range ballistic missiles into sea: JCS
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Samsung, SK hynix investors dump shares on Nvidia crash
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Suspect in murder of girlfriend's mugshot, name made public
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[더인베스터(코리아헤럴드)=박한나기자] 삼성바이오에피스가 개발한 유방암 치료제가 유럽서 출시되는 최초의 허셉틴 바이오시밀러가 될 것으로 보인다. “퍼스트무버”로서 시장선점에 청신호가 켜졌다.
애초 최초 출시가 유력했던 것은 인도제약사 바이오콘이었다. 하지만 이 회사가 지난 16일 생산시설 문제로 출시 철회를 공식화하면서 2순위였던 삼성바이오에피스의 SB3이 그 자리를 꿰차게 된 것이다.
바이오콘과 삼성바이오에피스는 각각 지난해 8월과 9월 한달 차이로 유럽의약품청에 허셉틴 바이오시밀러 출시 허가를 신청했고 이변이 없다면 두 곳 모두 올 가을께 판매승인을 받을 것으로 예상돼왔다.
퍼스트무버는 오리지널 의약품에 비해 저렴한 가격은 물론 후발 주자들보다 더 풍부한 임상데이터를 확보할 수 있기 때문에 이 자리를 놓고 제약업체들은 치열하게 경쟁을 벌이고 있다.
삼성바이오에피스 관계자는 “심사절차가 문제없이 잘 진행되고 있다”며 유럽출시에 자신감을 드러냈다.
바이오콘은 올해 4분기 다시 판매신청을 하겠다고 밝혔지만 이미 지난해 10월 판매신청을 한 셀트리온의 허쥬마 역시 이번 신청 철회로 수혜를 받을 것으로 예상된다.
삼성바이오에피스와 셀트리온이 순차적으로 올해 안에 판매허가를 받는다면 퍼스트, 세컨드 무버 지위를 얻어 유럽에서만 연매출 2조3천억원에 달하는 허셉틴 시장에서 우리나라 기업들끼리 각축을 벌이게 된다.
미국 바이오 전문지 바이오프로세스인터네셔널에 따르면, 바이오시밀러의 경우 퍼스트무버의 매출을 100%로 볼 때 두 번째로 진출하는 제품은 첫 제품 매출의 88%를 세 번째 출시되는 제품은 그 50%를 예상매출로 집계하고 있다.
(hnpark@heraldcorp.com)
<영문기사>
Samsung Bioepis likely to launch first Herceptin biosimilar in EU
[THE INVESTOR] Korean biotech firm Samsung Bioepis is expected to take the lead in the race to get a copycat version of Roche’s Herceptin to market in Europe, as India’s Biocon withdrew its filing.
Biocon, which had expected to be first to market in the EU with a copy of the blockbuster breast cancer drug, said on Aug. 16 that it would withdraw its application after the European Medicines Agency told the company it would need to re-inspect a drug production facility.
The withdrawal is a boon for other drugmakers rushing to be first with a copy. Especially, Samsung Bioepis, which was only weeks behind in applying for its version SB3 to the European drug regulator in September in 2016. “All we can say is that we are on track to gain EMA approval,” a Samsung Bioepis official told The Investor.
Holding “first mover advantage” is critical for biosimilar makers to establish market share amid fierce competition.
The US$2 billion EU market for Herceptin could become a new battlefield for Samsung Bioepis and its cross-town rival Celltrion, which filed for approval of its own Herceptin copy, Herzuma, in October last year.
The two Korean companies are expected to get green light to sell their biosimilar versions this autumn, as the EMA typically takes just over a year to approve a drug.
Apart from Herceptin, there is a lot of overlap between the two companies’ drug portfolios, including biosimilar versions of the world’s top selling branded therapies -- Enbrel, Remicade, Humira, Avastin and Rixutan.
Meanwhile, Biocon said it would seek resubmission next quarter while Allergan and Amgen also Amgen filed for EU approval of their Herceptin biosimilars in March.
By Park Han-na (hnpark@heraldcorp.com)
애초 최초 출시가 유력했던 것은 인도제약사 바이오콘이었다. 하지만 이 회사가 지난 16일 생산시설 문제로 출시 철회를 공식화하면서 2순위였던 삼성바이오에피스의 SB3이 그 자리를 꿰차게 된 것이다.
바이오콘과 삼성바이오에피스는 각각 지난해 8월과 9월 한달 차이로 유럽의약품청에 허셉틴 바이오시밀러 출시 허가를 신청했고 이변이 없다면 두 곳 모두 올 가을께 판매승인을 받을 것으로 예상돼왔다.
퍼스트무버는 오리지널 의약품에 비해 저렴한 가격은 물론 후발 주자들보다 더 풍부한 임상데이터를 확보할 수 있기 때문에 이 자리를 놓고 제약업체들은 치열하게 경쟁을 벌이고 있다.
삼성바이오에피스 관계자는 “심사절차가 문제없이 잘 진행되고 있다”며 유럽출시에 자신감을 드러냈다.
바이오콘은 올해 4분기 다시 판매신청을 하겠다고 밝혔지만 이미 지난해 10월 판매신청을 한 셀트리온의 허쥬마 역시 이번 신청 철회로 수혜를 받을 것으로 예상된다.
삼성바이오에피스와 셀트리온이 순차적으로 올해 안에 판매허가를 받는다면 퍼스트, 세컨드 무버 지위를 얻어 유럽에서만 연매출 2조3천억원에 달하는 허셉틴 시장에서 우리나라 기업들끼리 각축을 벌이게 된다.
미국 바이오 전문지 바이오프로세스인터네셔널에 따르면, 바이오시밀러의 경우 퍼스트무버의 매출을 100%로 볼 때 두 번째로 진출하는 제품은 첫 제품 매출의 88%를 세 번째 출시되는 제품은 그 50%를 예상매출로 집계하고 있다.
(hnpark@heraldcorp.com)
<영문기사>
Samsung Bioepis likely to launch first Herceptin biosimilar in EU
[THE INVESTOR] Korean biotech firm Samsung Bioepis is expected to take the lead in the race to get a copycat version of Roche’s Herceptin to market in Europe, as India’s Biocon withdrew its filing.
Biocon, which had expected to be first to market in the EU with a copy of the blockbuster breast cancer drug, said on Aug. 16 that it would withdraw its application after the European Medicines Agency told the company it would need to re-inspect a drug production facility.
The withdrawal is a boon for other drugmakers rushing to be first with a copy. Especially, Samsung Bioepis, which was only weeks behind in applying for its version SB3 to the European drug regulator in September in 2016. “All we can say is that we are on track to gain EMA approval,” a Samsung Bioepis official told The Investor.
Holding “first mover advantage” is critical for biosimilar makers to establish market share amid fierce competition.
The US$2 billion EU market for Herceptin could become a new battlefield for Samsung Bioepis and its cross-town rival Celltrion, which filed for approval of its own Herceptin copy, Herzuma, in October last year.
The two Korean companies are expected to get green light to sell their biosimilar versions this autumn, as the EMA typically takes just over a year to approve a drug.
Apart from Herceptin, there is a lot of overlap between the two companies’ drug portfolios, including biosimilar versions of the world’s top selling branded therapies -- Enbrel, Remicade, Humira, Avastin and Rixutan.
Meanwhile, Biocon said it would seek resubmission next quarter while Allergan and Amgen also Amgen filed for EU approval of their Herceptin biosimilars in March.
By Park Han-na (hnpark@heraldcorp.com)
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