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

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

Tamara Mathias  |  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, which is the world’s top-selling prescription medicine.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The drug, which treats rheumatoid arthritis, raked in $18.43 billion in sales last year and accounted for nearly two-thirds of AbbVie’s net revenue.

Although terms of the deal were undisclosed, AbbVie said it will make no payments to Samsung Bioepis and the three companies agreed to dismiss all pending lawsuits.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Even if multiple Humira biosimilars are delayed from market until 2023, this can be “more than offset” by a steeper sales decline for Humira, BMO Capital Markets analyst Alex Arfaei says.

Arfaei notes this is increasingly likely given the U.S. Food and Drug Administration‘s encouraging stance on the approval of biosimilar drugs and fewer chances of drugmakers negotiating with insurers to gain preferred coverage of their drugs over rivals.

Samsung Bioepis’ license to market its biosimilar will kick off on June 30, 2023, after which Samsung will pay royalties to license Humira patents, AbbVie said in a statement.

Samsung Bioepis is partnered with Biogen to market the drug in Europe and Merck & Co to market it in the U.S.

Biogen expects to launch the biosimilar, Imraldi, in Europe in mid-October this year.

In September, Amgen Inc. reached a similar settlement with AbbVie to delay the U.S. launch of its cheaper biosimilar to adalimumab until Jan. 31, 2023.

Jefferies analyst Ian Hilliker notes the deal with Samsung Bioepis enables a biosimilar launch some months after Amgen, making it increasingly unlikely other rivals will be able to negotiate settlements that allow their launches before 2023.

Shares of AbbVie, which has been focusing on developing cancer drugs to sustain long-term growth, have been under pressure in recent months hurt by a failed trial of an experimental lung cancer treatment, Rova-T.

Share: 

Filed under:Biologics/DMARDsDrug Updates Tagged with:AbbVieadalimumabBiosimilarsHumiraSamsung Bioepis

Related Articles

    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.

    Samsung Bioepis Receives Final European Approval for Its Remicade Copy

    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…

    FDA Expands Label for Insulin Degludec; Adalimumab Biosimilar Moves Forward After Legal Battle

    April 18, 2018

    The FDA has expanded the label for insulin degludec to include data on improved cardiovascular outcomes and deceased severe hypoglycemia…

    Cliff Diving: Evergreening & Other Oddities

    September 5, 2022

    The glassblowers were in revolt. The island of Murano, in the 13th century, was a perfect home for the glassblowing industry. Connected to Venice through a system of bridges, Murano was surrounded by waters that protected the city from the furnaces that fueled the glassblowers’ craft. The Republic of Venice dominated trade throughout the Mediterranean,…

  • 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