BOOKMARK
  • Korean|
  • Chinese|
  • Japanese|
  • Vietnamese
본문내용 바로가기

Aju Business Daily

SEARCH
World's top technology exhibition CES 2021
  • ECONOMY
  • ENTERTAINMENT
  • IT
  • South Korea
  • North Korea
  • WORLD
  • SPORTS
  • LIFESTYLE
  • AUTO MOTIVE
  • OPINION
  • PEOPLE
  • MILITARY
Home > Health > article

Celltrion acquires European approval to sell Remsima SC for treatment of rheumatoid arthritis

Lim Chang-won Reporter(cwlim34@ajunews.com) | Posted : November 26, 2019, 10:53 | Updated : November 26, 2019, 10:53
  • 트위터
  • 페이스북
  • 웨이보

[Courtesy of Celltrion]


SEOUL -- Celltrion, a bio firm in South Korea, has acquired final approval to sell Remsima SC, the subcutaneous injection of Remsima, a copy of Janssen Biotech's Remicade treating rheumatoid arthritis, in Europe, opening the way for worldwide distribution. The company plans to acquire U.S. approval in 2022.

Celltrion said on Tuesday that the European Medicines Agency (EMA), an EU agency in charge of the evaluation and supervision of medicinal products, has approved the marketing of Remsima SC. The company sent an application in November last year to EMA for marketing permission in an effort to recognize Remsima SC as a "biobetter," which is evaluated as a new drug.

A biosimilar has no clinically meaningful differences in terms of safety and effectiveness from its reference product. Biobetters, an improved version of existing products, may have a change in structure that makes it safer or more effective or a change in the formulation that makes it easier to administer or allows fewer courses of treatment.

The target of Remsima SC is patients who are forced to move on to expensive secondary treatments due to resistance. Celltrion suggests Remsima SC is more expensive than primary treatment but cheaper than secondary treatment, enabling active prescription for patients with resistance. Instead of an intravenous injection that takes more than two hours in hospital, patients can inject Remsima SC into the fat layer beneath the skin at home.

Direct sales in Europe would be made by Celltrion Healthcare, which is responsible for overseas marketing and distribution. With Remsima SC, Celltrion has adopted an aggressive strategy to secure profitability and price penetration in competition with other subcutaneous-type products such as Adalimumab, sold under the brand name of Humira, which is on the World Health Organization's List of essential medicines.

  • Lim Chang-won Reporter
  • email : cwlim34@ajunews.com
© Aju Business Daily & www.ajunews.com Copyright: All materials on this site may not be reproduced, distributed, transmitted, displayed, published or broadcast without the authorization from the Aju News Corporation.
  • twitter
  • facebook
  • weibo
  • link copy
  • LIST
  • TOP

Related news

  • .GC Pharmas plasma treatment allowed for actual use in treating COVID-19 patients.
    GC Pharma's plasma treatment allowed for actual use in treat…
  • .Celltrion leaves door open for consignment production of COVID-19 vaccines.
    Celltrion leaves door open for consignment production of COV…
  • . Celltrion revises deal with U.S. client to ship new rapid COVID-19 antigen test kit.
    Celltrion revises deal with U.S. client to ship new rapid C…
  • .Anti-epidemic center considers introducing rapid antigen inspection.
    Anti-epidemic center considers introducing rapid antigen ins…
  • .Celltrion wins $185 mln deal to sell rapid COVID-19 test kit to U.S..
    Celltrion wins $185 mln deal to sell rapid COVID-19 test kit…

Real Time Photo News

  • .Singer IU drops teaser image for upcoming full album.

    Singer IU drops teaser image for upcoming full album

  • .Cube Entertainment partners with web comics company to create online video content.

    Cube Entertainment partners with web comics company to create online video content

  • .Sci-fi film starring Song Joong-ki to be reelased on Netflix in February.

    Sci-fi film starring Song Joong-ki to be reelased on Netflix in February

  • .Actor Kim Soo-hyun to star in S. Korean remake of British TV drama series Criminal Justice.

    Actor Kim Soo-hyun to star in S. Korean remake of British TV drama series 'Criminal Justice'

  • .CJ ENM partners with NCSoft to roll out new digital content for global market.

    CJ ENM partners with NCSoft to roll out new digital content for global market

Latest News

more+

  • Singer IU drops teaser image for upcoming full album
  • Hyundai to complete construction of fuel cell production plant in China in 2022
  • Seoul builds solar power plant on idle land near urban expressway
  • Samsung showcases new Galaxy S21 smartphone models
  • Southern city launches joint research project to develop heavy-duty flying taxi drone
Aju Business Daily
  • ABOUT US
  • CONTACT US
  • PRIVACY STATEMENT
  • Copyright Policy

Address : Aju News Corporation LEEMA Building, 11th floor, 42, Jong-ro 1-gil, Jongno-gu, Seoul.    Mail : swatchsjp@ajunews.com

Copyright ⓒ 2016 By Ajunews Corporation, All Rights Reserved.

Mobile view