The Rheumatologist
COVID-19 NewsACR Convergence
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Gout Resource Center
      • Axial Spondyloarthritis Resource Center
      • Psoriatic Arthritis
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / Novartis Biosimilar Takes Aim at Amgen’s Enbrel

Novartis Biosimilar Takes Aim at Amgen’s Enbrel

October 2, 2015 • By Michael Shields & Ben Hirschler

  • Tweet
  • Email
Print-Friendly Version / Save PDF

ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday.

You Might Also Like
  • Novartis Bid to Sell New Biosimilar Crimped by U.S. Court Battles
  • FDA Panel Supports Novartis Biosimilar of Etanercept
  • Novartis Launches First U.S. Biosimilar Drug at 15% Discount

Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014 with sales of nearly $9 billion.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Amgen, which sells the drug in North America, booked Enbrel sales of $4.7 billion last year. Pfizer sells Enbrel elsewhere.

Merck and Samsung Bioepis last month won approval for biosimilar etanercept in South Korea and a copy is also on the way in Europe, where Samsung is working with Biogen, but Sandoz said it believed it was the first company to receive a U.S. FDA file acceptance.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Sandoz is seeking approval for all indications included in the label for Enbrel, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis, it said in a statement.

Novartis last month launched the first biosimilar drug in the U.S. after an appeals court there declined to stop the sale of the company’s copycat version of Amgen’s blockbuster cancer drug Neupogen (filgrastim).

Insurers and government healthcare systems hope biosimilars will cost the public 40% to 50% less than the original drugs and experience in Europe suggests that steep discounts are being offered in some markets.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

“Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product,” Novartis said on Friday.

The potential for biosimilars to take a large slice of the market is grabbing the attention of both healthcare providers, who see big budget savings, and investors, worried about the impact on the profits of companies making original products.

 

Filed Under: Biologics & Biosimilars, Drug Updates, Pharma Co. News Tagged With: Amgen, anti-TNF agent, etanercept, FDA, Food and Drug Administration, Novartis

You Might Also Like:
  • Novartis Bid to Sell New Biosimilar Crimped by U.S. Court Battles
  • FDA Panel Supports Novartis Biosimilar of Etanercept
  • Novartis Launches First U.S. Biosimilar Drug at 15% Discount
  • Novartis Receives EU Approval for Infliximab Biosimilar Zessly

Simple Tasks

Learn more about the ACR’s public awareness campaign and how you can get involved. Help increase visibility of rheumatic diseases and decrease the number of people left untreated.

Visit the Simple Tasks site »

ACR Convergence

Don’t miss rheumatology’s premier scientific meeting for anyone involved in research or the delivery of rheumatologic care or services.

Visit the ACR Convergence site »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use / Cookie Preferences

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2023 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)