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셀트리온 "허쥬마, 캐나다 시판허가" - 바이오스펙테이터

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셀트리온 "허쥬마, 캐나다 시판허가"

입력 2019-09-10 09:59 수정 2019-09-10 09:59

바이오스펙테이터 조정민 기자

캐나다 보건부 "허쥬마 안전성 및 효능, 오리지널의약품과 동등"..테바 통해 론칭 예정

셀트리온은 최근 캐나다 보건부로부터 유방암 위암 치료용 바이오시밀러 '허쥬마(Herzuma)' 시판 허가를 획득했다고 10일 밝혔다. 셀트리온은 작년 12월 미국 식품의약국(FDA) 판매 허가에 이어 캐나다까지 북미시장 진입을 앞두게 됐다.

허쥬마는 로슈가 개발한 '허셉틴(성분명 트라스투주맙)'의 바이오시밀러로 초기 유방암, 전이성 유방암 및 전이성 위암 등 3개 적응증에 대해 판매 허가를 획득했다.

캐나다 보건부는 비임상 및 임상시험의 종합적인 데이터를 검증한 결과 세 적응증에 대한 허쥬마의 안전성과 효능이 오리지널의약품과 동등함을 입증했다고 밝혔다.

허셉틴은 지난해 기준 연간 글로벌 매출이 8조 7000억에 이르는 블록버스터 의약품으로 이 중 미국, 캐나다 등 북미시장에서만 3조 5000억원의 매출을 거뒀다.

셀트리온 의약품의 해외 유통 및 마케팅을 담당하는 셀트리온헬스케어는 북미지역 유통 파트너인 테바(TEVA)와 협의해 론칭 시점을 결정할 계획이다.

셀트리온 관계자는 "지난 2014년 램시마가 캐나다 시장에 처음 진출했고 트룩시마도 올해 4월 승인을 받아 출시를 앞두고 있다"며 "이번 허쥬마 승인까지 셀트리온 항체 바이오시밀러 제품 3종이 미국과 캐나다에서 모두 판매 허가를 받은 만큼 북미 지역 환자들에게 고품질의 바이오의약품을 공급하기 위해 최선을 다하겠다"고 말했다.

한편, 캐나다는 지난 5월 오리지널의약품을 바이오시밀러로 대체처방하는 바이오시밀러 확대 정책을 도입, 의료 재정 절감 및 환자 접근성을 강화하겠다고 발표하는 등 바이오시밀러 장려 정책을 추진하고 있다.

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