Korean biosimilar companies seek app... > IT/과학기사 | it/science

본문 바로가기
사이트 내 전체검색

IT/과학기사 | it/science

Korean biosimilar companies seek app...

페이지 정보

profile_image
작성자 수집기
댓글 0건 조회 43회 작성일 23-06-01 11:27

본문

뉴스 기사
news-p.v1.20230601.0cd7178b8eb044389d192373382563b4_P1.jpg


South Korean biosimilar companies are scrambling to gain approvals in major markets, following the patent expiry of a series of blockbuster drugs including Humira, the world’s top-selling drug that acts on the immune system, and autoimmune disease treatment Stelara.

According to multiple industry sources on Thursday, Dong-A ST Co. plans to file a license application for its Stelara biosimilar DMB-3115 in the U.S. and Europe in June.

The patent of Stelara, which saw global sales reach $9.7 billion last year, is set to expire in September in the U.S. and September next year in Europe.

It is the first time for Dong-A ST to enter the major markets with a self-developed biosimilar.

Other biosimilar companies Celltrion Inc. and Samsung Bioepis Co. have also completed phase-three clinical trials for their copied products of Stelara.

Celltrion has finished filing an application for the approval of its product with the European Medicines Agency EMA last week.

It is highly likely that Icelandic biosimilar drugmaker Alvotech SA that applied for approval in the U.S. and Europe early this year will be the first to receive approval for a Stelara biosimilar.

The U.S. patent for Eylea, which was jointly developed by Regeneron Pharmaceuticals Inc. of the U.S. and Bayer AG of Germany, expires in June.

Among Korean players, Samsung Bioepis, Celltrion, Samcheondang Pharmaceutical Co., and Alteogen Inc. jumped into the Eylea market that boasts annual sales of $7.7 billion.

Samsung Bioepis and Samchundang Pharmaceutical have completed phase-three clinical trials globally. Samcheondang Pharmaceutical, which will make a debut in the biosimilar market with the Eylea biosimilar SCD411 is pursuing a contract with a European pharmaceutical company for licensing in Europe in July.

Patent litigation, however, emerges as a new risk in the market as Eylea developer Regeneron Pharmaceuticals has filed infringement lawsuits against Viatris Inc. and Samsung Bioepis to defend patent rights.

“이게 4만원, 먹다 남긴 거 절대 아닙니다”...축제 바가지에 ‘시끌시끌’

한국주택 보유 1위는 왕서방...토지는 뜻밖에도 이 나라가 최다

‘조국 딸 저격’ 강용석 “외제차 몬적 없다더니 계속 타”…조민 반응은

‘외제차 몬 적 없다’던 조민, 이번엔 벤츠 운전…“자수성가 친구 차”

가슴 만진 男에 3천만원 요구한 女…“고소보다 낫다” 협박

댓글목록

등록된 댓글이 없습니다.

회원로그인

회원가입

사이트 정보

회사명 : 원미디어 / 대표 : 대표자명
주소 : OO도 OO시 OO구 OO동 123-45
사업자 등록번호 : 123-45-67890
전화 : 02-123-4567 팩스 : 02-123-4568
통신판매업신고번호 : 제 OO구 - 123호
개인정보관리책임자 : 정보책임자명

접속자집계

오늘
551
어제
547
최대
2,563
전체
345,790
Copyright © 소유하신 도메인. All rights reserved.