담양 창평 슬로시티

NO.1: 담양 창평 슬로시티

삼성바이오에피스 [삼성바이오에피스 제공.재판매 및 DB 금지]

삼성바이오에피스
[삼성바이오에피스 제공.재판매 및 DB 금지]

(서울=연합뉴스) 김현수 기자 = 삼성바이오에피스가 미국 식품의약청(FDA)으로부터 자가면역질환 치료제 스텔라라의 바이오시밀러(바이오의약품 복제약) '피즈치바'(성분명 우스테키누맙·프로젝트명 SB17)의 품목 허가를 받았다고 2일 밝혔다.

이번 허가에 따라 삼성바이오에피스는 미국에서 총 7개의 바이오시밀러 품목 허가를 받게 됐으며,SB17은 한국·유럽에 이어 세 번째 품목 허가를 받았다.

스텔라라는 세계적 제약사 얀센이 개발한 자가면역질환 치료제로,담양 창평 슬로시티염증 유발과 관련한 물질인 인터루킨(IL)-12,담양 창평 슬로시티23 활성을 억제해 판상 건선,담양 창평 슬로시티건선성 관절염,크론병,담양 창평 슬로시티궤양성 대장염 등에 처방된다.

삼성바이오에피스 규제 업무(RA) 팀장 정병인 상무는 "자가면역질환 치료제 중 첫 인터루킨 억제제인 피즈치바의 미국 허가를 받아 기쁘다"며 "다양한 분야의 의약품 개발을 통해 환자들에게 더 많은 치료 옵션을 제공할 수 있도록 노력하겠다"고 전했다.

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