Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 530

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 530

Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 531
셀트리온 "고농도 휴미라 시밀러, 상반기 EMA 허가 신청" - 바이오스펙테이터

본문 바로가기

바이오스펙테이터

기사본문

셀트리온 "고농도 휴미라 시밀러, 상반기 EMA 허가 신청"

입력 2020-01-17 08:16 수정 2020-01-17 09:13

바이오스펙테이터 샌프란시스코(미국)=장종원 기자

램시마SC도 염증성 장질환(IBD) 적응증으로 확장 신청

셀트리온이 고농도 제형의 휴미라 바이오시밀러 ‘CT-P17’의 유럽 허가 절차에 돌입한다.

서정진 셀트리온그룹 회장은 15일(현지시간) 미국 샌프란시스코에 열린 JP모건 헬스케어 컨퍼런스에서 "올해 상반기에 유럽의약품청(EMA)에 CT-P17 의 허가를 신청할 계획"이라고 밝혔다.

CT-P17은 블록버스터 의약품인 휴미라의 바이오시밀러로, 셀트리온은 기존 바이오시밀러와 차별화한 전략으로 투여량을 줄여 환자 편의성을 강조한 고농도 제형으로 개발해 왔다. 현재 고농도 제형으로는 셀트리온 바이오시밀러가 유일하다. 또한 기존 휴미라 바이오시밀러와 달리 주사 시 통증을 유발할 수 있는 구연산염을 제거한 CF(Citrate Free) 제형으로 개발되고 있다.

이와 함께 셀트리온은 램시마피하주사제형(SC)의 적응증을 류마티스관절염에서 IBD 등으로 확장하기 위한 허가신청을 지난 14일 마쳤다. 셀트리온은 램시마SC의 빠른 허가를 위해 류마티스관절염 적응증으로 우선 허가를 받고 이후 IBD 등 다른 적응증으로 확장하는 전략을 추진해왔다. 램시마SC는 작년 11월말 유럽 판매 승인을 받아 올해 2월 독일부터 출시된다.

이상준 셀트리온 수석부사장은 "이미 허가 받은 류마티스 관절염을 제외한 강직성 척추염(AS), 크론병(CD), 궤양성대장염(UC) 등 인플릭시맙의 모든 적응증을 추가하기 위한 것"이라면서 "올해 상반기내 결과가 나올 것으로 기대한다"고 말했다.

카카오스토리로 기사 공유하기