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삼성바이오에피스, 韓·美 '아일리아 시밀러' 3상 승인 - 바이오스펙테이터

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삼성바이오에피스, 韓·美 '아일리아 시밀러' 3상 승인

입력 2020-06-15 09:43 수정 2020-06-15 09:43

바이오스펙테이터 장종원 기자

국내 10곳 의료기관에서 진행..임상 1상은 면제

삼성바이오에피스가 황반변성 치료제 아일리아(성분명 애플리버셉트) 바이오시밀러 개발을 위한 글로벌 임상 3상에 돌입한다.

15일 식품의약품안전처에 따르면 삼성바이오에피스는 최근 SB15와 아일리아간 유효성, 안전성, 약동학 및 면역원성을 비교하는 국내 임상 3상을 승인받았다. 임상 1상은 면제받았다.

SB15는 삼성바이오에피스가 개발하는 아일리아 바이오시밀러로 이번 3상은 서울아산병원을 비롯해 국내 10곳의 의료기관에서 진행된다.

이에 앞서 삼성바이오에피스는 미국 식품의약국(FDA)으로부터 SB15의 임상 3상 승인도 받았다. 현재 한국, 미국을 포함한 총 8개국에서 임상 3상을 승인받은 것으로 알려졌다.

아일리아는 리제네론(Regeneron)과 바이엘(Bayer)이 개발한 황반변성 치료제로 지난해 매출은 65억5100만달러(약 7조8000억원)에 이른다. 삼성바이오에피스는 지난해 11월 바이오젠과 아일리아 바이오시밀러 개발에 대한 판권계약을 체결한 바 있다.

삼성바이오에피스는 지난 5월 또다른 황반변성 치료제인 루센티스 바이오시밀러(SB11) 3상의 1차 유효성 평가 지표를 충족했다고 밝힌바 있다. SB11은 올해 유럽, 미국 등을 대상으로 품목허가 절차에 돌입할 계획이다.

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