Video: Every Case Tells a Story| Webinar: ACR/CHEST ILD Guidelines in Practice

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

  • Conditions
    • Axial Spondyloarthritis
    • Gout and Crystalline Arthritis
    • Myositis
    • Osteoarthritis and Bone Disorders
    • Pain Syndromes
    • Pediatric Conditions
    • Psoriatic Arthritis
    • Rheumatoid Arthritis
    • Sjögren’s Disease
    • Systemic Lupus Erythematosus
    • Systemic Sclerosis
    • Vasculitis
    • Other Rheumatic Conditions
  • FocusRheum
    • ANCA-Associated Vasculitis
    • Axial Spondyloarthritis
    • Gout
    • Psoriatic Arthritis
    • Rheumatoid Arthritis
    • Systemic Lupus Erythematosus
  • Guidance
    • Clinical Criteria/Guidelines
    • Ethics
    • Legal Updates
    • Legislation & Advocacy
    • Meeting Reports
      • ACR Convergence
      • Other ACR meetings
      • EULAR/Other
    • Research Rheum
  • Drug Updates
    • Analgesics
    • Biologics/DMARDs
  • Practice Support
    • Billing/Coding
    • EMRs
    • Facility
    • Insurance
    • QA/QI
    • Technology
    • Workforce
  • Opinion
    • Patient Perspective
    • Profiles
    • Rheuminations
      • Video
    • Speak Out Rheum
  • Career
    • ACR ExamRheum
    • Awards
    • Career Development
  • ACR
    • ACR Home
    • ACR Convergence
    • ACR Guidelines
    • Journals
      • ACR Open Rheumatology
      • Arthritis & Rheumatology
      • Arthritis Care & Research
    • From the College
    • Events/CME
    • President’s Perspective
  • Search

Samsung Bioepis Receives Final European Approval for Its Remicade Copy

Reuters Staff  |  June 1, 2016

SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe.

Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar had been submitted for review in the U.S.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

A relative latecomer to the industry, Samsung Bioepis has found early success by beating rivals to market on some of the world’s top-selling drugs. It became the first company to launch a biosimilar version of Amgen’s Enbrel (etanercept), another rheumatoid arthritis drug, in Europe.

Samsung Biologics, Bioepis’ parent company, is planning an initial public offering in South Korea by the end of the year that analysts say could raise up to 3 trillion won ($2.5 billion).

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Samsung Bioepis says minority shareholder and partner Biogen will be responsible for the commercialisation and distribution of its Remicade copy, called Flixabi in Europe.

Biosimilars, lower-cost copies of complex biotech drugs, are still relatively new but interest is growing quickly as firms, such as Bioepis, launch cheaper versions of blockbuster drugs.

The Samsung Group hopes the biosimilars business will develop into a new growth driver as global demand for smartphones plateaus, weighing on the outlook for its flagship firm Samsung Electronics.

Share: 

Filed under:Biologics/DMARDsDrug Updates Tagged with:Biosimilarsinfliximabinfliximab-dyybInternationalRemicade

Related Articles

    Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

    September 8, 2016

    The use of biosimilars for rheuma­tology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…

    Marching to the Biosimilar Beat: Questions on Rollout Remain

    September 7, 2023

    The availability of biosimilars for the treatment of patients with rheumatic diseases exploded in 2023. Here’s where we stand and what to expect going forward.

    Medicalwriters/Science Source

    Biosimilars Are Slowly Climbing Toward Acceptance in Rheumatology

    June 15, 2020

    As useful stand-ins for biologics targeting a range of inflammatory diseases, biosimilars have made significant inroads across Europe as less expensive alternatives. Denmark, for example, realized a cost savings of 64% after instituting a mandatory national switch from the originator infliximab to its biosimilar counterpart. In the U.S., however, a considerably smaller fraction of rheumatologists…

    AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023

    April 8, 2018

    (Reuters)—AbbVie Inc. on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc. that would fend off U.S. competition of their biosimilar version to blockbuster drug, adalimumab (Humira), until 2023. This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira,…

  • About Us
  • Meet the Editors
  • Issue Archives
  • Contribute
  • Advertise
  • Contact Us
  • Copyright © 2025 by John Wiley & Sons, Inc. All rights reserved, including rights for text and data mining and training of artificial technologies or similar technologies. ISSN 1931-3268 (print). ISSN 1931-3209 (online).
  • DEI Statement
  • Privacy Policy
  • Terms of Use
  • Cookie Preferences