로또 스피또 비교 - ID=2024-10-19%2Fuoqcaa.html

로또 스피또 비교 - 2024년 실시간 업데이트

셀트리온
[연합뉴스TV 캡처.재판매 및 DB 금지]

(서울=연합뉴스) 김현수 기자 = 셀트리온이 면역항암제 '키트루다'(성분명 펨브롤리주맙)의 바이오시밀러(바이오의약품 복제약)인 CT-P51의 임상 3상 시험 계획(IND)을 미국 식품의약청(FDA)에 신청했다고 17일 밝혔다.

승인이 나면 셀트리온은 전이성 비소세포폐암 환자 606명을 대상으로 오리지널약과 CT-P51의 유효성,로또 스피또 비교동등성을 입증할 계획이다.

키트루다는 세계적 제약사 MSD(머크)가 개발한 블록버스터 의약품으로,로또 스피또 비교지난해 매출이 250억 달러(약 33조8천억원)를 기록하며 전 세계 매출 1위 의약품에 올랐다.

키트루다는 미국과 유럽에서 각각 2029년 11월,로또 스피또 비교2031년 1월에 물질 특허가 만료될 예정이어서 각국 제약 기업들은 키트루다 복제약 개발에 뛰어들고 있다.

셀트리온은 2025년까지 11개 바이오시밀러 포트폴리오를 확보할 방침이다.

셀트리온 관계자는 "CT-P51의 오리지널 제품은 현재 세계에서 가장 큰 매출을 올리는 등 글로벌 면역항암제 시장이 폭발적 성장세를 보여 CT-P51의 매출 잠재력은 무궁무진할 것으로 예상한다"고 말했다.

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