Samsung Bioepis' Humira biosimilar approved both in high and low concentration in US

Minu Kim 2022. 8. 18. 13:39
글자크기 설정 파란원을 좌우로 움직이시면 글자크기가 변경 됩니다.

이 글자크기로 변경됩니다.

(예시) 가장 빠른 뉴스가 있고 다양한 정보, 쌍방향 소통이 숨쉬는 다음뉴스를 만나보세요. 다음뉴스는 국내외 주요이슈와 실시간 속보, 문화생활 및 다양한 분야의 뉴스를 입체적으로 전달하고 있습니다.

[Source: Samsung Bioepis Co.]
The U.S. Food and Drug Administration (FDA) has approved a high-concentration (100 mg/mL) formulation of Hadlima, a biosimilar from Samsung Bioepis Co., which references Humira (adalimumab) from AbbVie, the Korean biopharmaceutical company said on Thursday.

Hadrima is indicated for the treatment of autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis, among others.

Hadlima was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019. The latest approval enables availability in both low and high concentration adalimumab biosimilar.

Under a patent agreement with AbbVie, Hadlima is expected to be launched on or after July 2023 by Organon & Co. in the U.S.

Hadlima is marketed by Biogen under the trade name of Imraldi in Europe and by Yuhan under the trade name of Adalloce in Korea. It was launched in October 2018 in Europe and May 2021 in Korea, with over 5 million doses sold since 2018.

[ⓒ Maeil Business Newspaper &, All rights reserved]

Copyright © 매일경제 & 무단 전재, 재배포 및 AI학습 이용 금지

이 기사에 대해 어떻게 생각하시나요?