The Rheumatologist
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • 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
  • Technology
    • Electronic Health Records
    • Apps
    • Information Technology
  • Resources
    • Issue Archives
    • Events
    • Multimedia
      • Audio
      • Video
    • From the College
    • American College of Rheumatology
    • Rheumatology Research Foundation
    • Arthritis & Rheumatology
    • Arthritis Care & Research
    • Treatment Guidelines
    • Research Reviews
    • Annual Meeting
      • Abstracts
      • Meeting Reports
    • Rheumatology Image Bank
    • ACR ExamRheum
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / Generic TNF-Alpha Inhibitors Comparable to Established Brands

Generic TNF-Alpha Inhibitors Comparable to Established Brands

August 3, 2016 • By David Douglas

  • Tweet
  • Email
Print-Friendly Version / Save PDF

NEW YORK (Reuters Health)—Biosimilar tumor necrosis factor-alpha inhibitors appear equivalent to the branded original versions, according to a systematic review and meta-analysis.

You Might Also Like
  • Newer Biologics for RA on Par with TNF-Inhibitors for CV Risk
  • When Will Generic Biologic Drugs Become Commercially Available?
  • Anti-TNF-Alpha Agents May Improve Endothelial Function Patients with RA

As Dr. G. Caleb Alexander tells Reuters Health by email, “biologic treatments represent a rapidly growing proportion of prescription drug expenditures and thus there is enormous interest in whether or not biosimilar products are truly biosimilar.”

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

“Our results,” he adds, “suggest that, for this important class of drugs, the biosimilar versions appear to have the same safety and efficacy profiles as their branded counterparts (or as the originator products).”

In a paper online Aug. 1 in Annals of Internal Medicine, Dr. Alexander of Johns Hopkins Bloomberg School of Public Health in Baltimore and colleagues point out that there are five innovator TNF-alpha inhibitors on the U.S. market: adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi) and infliximab (Remicade).

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

In April 2016, they add, “the FDA approved the infliximab biosimilar, Inflectra, which is only the second biosimilar to receive market approval in the United States.”

The agent is already available in Canada, Australia, Korea and other countries. Other biosimilars are also available. For example, Korea has two approved etanercept biosimilars, and India currently has a handful of marketed biosimilars.

To investigate their performance, the team examined outcome in 19 studies. Eight were Phase I randomized trials, five were Phase III randomized trials and six were observational studies. Among participants were healthy volunteers, patients with inflammatory bowel disease, patients with ankylosing spondylitis and patients with rheumatoid arthritis.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

Comparisons included CT-P13 vs. infliximab, SB4 and TuNEX vs. etanercept and ZRC-3197 vs. adalimumab.

The Phase I trials, say the researchers, showed that the pharmacokinetic parameters of the agents were within the prespecified equivalence margin.

The Phase III trials “suggested similar clinical responses and adverse events.” That was also the case in four cohort studies in patients who switched from infliximab to CT-P13, but cross-reactivity was seen in two studies.

Dr. Alexander concludes, “there has been considerable uncertainty as to whether biosimilar products are as safe and effective as their referent or originator, or branded counterparts, our results suggest that they at least in this case, are.”

In an accompanying editorial, Drs. Issam Zineh and Leah A. Christl of the U.S. Food and Drug Administration in Silver Spring, Md., note that, “In our experience, randomized, comparative, noninferiority studies of clinical outcomes alone are generally considered insufficiently sensitive to detect the impact of product differences between a proposed biosimilar and its reference product.”

Pages: 1 2 | Single Page

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: Biosimilars, clinical trials, Rheumatoid Arthritis (RA), TNF-Alpha inhibitor

You Might Also Like:
  • Newer Biologics for RA on Par with TNF-Inhibitors for CV Risk
  • When Will Generic Biologic Drugs Become Commercially Available?
  • Anti-TNF-Alpha Agents May Improve Endothelial Function Patients with RA
  • RA Effectiveness Differs Among Non-TNF Inhibitors

ACR/ARP Annual Meeting

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

Visit the ACR Annual Meeting site »

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 »

Rheumatology Research Foundation

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

Learn more »

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 © 2006–2019 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.