The Rheumatologist
COVID-19 News
  • 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
    • Ankylosing Spondylitis Resource Center
    • Gout 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
  • 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
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • 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 / FDA Panel Supports Novartis Biosimilar of Etanercept

FDA Panel Supports Novartis Biosimilar of Etanercept

July 14, 2016 • By Reuters Staff

  • Tweet
  • Email
Print-Friendly Version / Save PDF

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday.

You Might Also Like
  • U.S. FDA Approves Biosimilar to Etanercept
  • FDA Panel Backs Amgen Biosimilar of Humira
  • Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting

The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made of living cells, and etanercept.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Etanercept has been approved to treat multiple conditions, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Novartis tested the drug, GP2015, in patients with plaque psoriasis, but if approved by the FDA, it would be approved for all sought conditions.

On Tuesday, the panel voted unanimously in favor of approval for Amgen’s biosimilar version of AbbVie Inc’s arthritis drug adalimumab (Humira).

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

The FDA is not obliged to follow the advice of its advisory panels, but typically does so.

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: Amgen, Biosimilars, etanercept, FDA, Food and Drug Administration, GP2015, Novartis

You Might Also Like:
  • U.S. FDA Approves Biosimilar to Etanercept
  • FDA Panel Backs Amgen Biosimilar of Humira
  • Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting
  • FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

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 »

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

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

Copyright © 2006–2021 American College of Rheumatology. All rights reserved.

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

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.