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 / The ACR Recommends Cautious Approach as Biosimilars Enter U.S. Market

The ACR Recommends Cautious Approach as Biosimilars Enter U.S. Market

March 17, 2015 • By Richard Quinn

  • Tweet
  • Email
Print-Friendly Version / Save PDF

Biosimilar drugs have the potential to reduce costs for patients with rheumatic diseases, but two rheumatologists and the American College of Rheumatology’s (ACR’s) recently updated position paper on the topic make clear that because creating and perfecting biosimilars are so difficult, taking a judicious approach makes sense.

You Might Also Like
  • Most Rheumatologists Want FDA to Better Regulate Biosimilars
  • Biosimilars to Raise Unique Questions
  • As Biosimilars Hit, EU Pharma Warns against Blanket Prescribing
Also By This Author
  • Kawasaki Disease Spread May be Linked to Wind

“As we move into biosimilars in this country, we have to be extremely cautious,” says Kwas Huston, MD, a member of the ACR’s Committee on Rheumatologic Care. “We have to have the confidence that these drugs will be as effective and safe as the original drug.”

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The process, of course, takes time. On March 6, the U.S. Food and Drug Administration announced it had approved the first biosimilar drug, Zarxio, a cancer treatment. The potential for biosimilars for rheumatic diseases is something the ACR supports, but “decisions regarding approval of biosimilars must be driven by sound science,” the ACR’s position paper reads.

To that end, the ACR’s position highlights calls to action on both the federal and state levels. In particular, the College is calling for:

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

—Rigorous clinical trials to ensure safety, efficacy and interchangeability of biosimilars with their base biologic.

—Safeguards to prevent repeated switching among biosimilars, because the potential adverse effects of switching are not yet known.

—Distinctive names for biosimilars compared with their original biologic. Names that could confuse patients or physicians make no sense and could make reporting and cataloguing of adverse effects more difficult.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

—Long-term surveillance and adverse-event tracking.

“We will continue to follow the various issues surrounding the distribution, monitoring and reimbursement of biosimilars very closely as state and federal policies are proposed that affect our patients and the rheumatologists who serve them,” ACR President E. William St.Clair, MD, FACR, says in a statement. “Ensuring patients have easy access to affordable treatment options and rheumatology care continues to be a high priority for us.”

William Harvey, MD, MSc, FACR, chair of the ACR’s Committee on Government Affairs, says the path to that affordable treatment option requires more rules because it’s more complex than that of standard generics.

“Clinical trials must be rigorous and explore the impact and safety of switching in particular,” Dr. Harvey writes in an e-mail interview. “Further, all biosimilars are not exactly the same. If a typical drug is as complicated as a word of text in terms of its make-up, then a biologic (or biosimilar) is like the entire chapter of a book. Misspelling one word in that chapter means the biosimilar, while still having a similar effect, could have a different immune response. The immune system’s job is to find that one misspelled word (if it is a bacteria or virus) and attack it, so it is entirely plausible that small differences that don’t impact efficacy of the biosimilar COULD impact its immune effects.

Pages: 1 2 | Single Page

Filed Under: Practice Management Tagged With: ACR/ARHP, Biosimilars, Drugs, FDA, patient safety, rheumatologist, Treatment

You Might Also Like:
  • Most Rheumatologists Want FDA to Better Regulate Biosimilars
  • Biosimilars to Raise Unique Questions
  • As Biosimilars Hit, EU Pharma Warns against Blanket Prescribing
  • The ACR’s Advocacy at State Legislature Level in 2016 Focuses on Biosimilars, Step Therapy

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 »

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 »

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.