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

Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?

Vanessa Caceres  |  Issue: October 2017  |  October 17, 2017

“It doesn’t make sense to require multiple trials [for extrapolation],” Dr. Cohen says. “Most of the work has been done with assays that determine this is a highly similar molecule, with no impact on efficacy or safety.” Although this may involve some griping from certain specialists—say, gastroenterologists who may not have data available from specific studies of the biosimilar conducted in patients with ulcerative colitis or Crohn’s disease—Dr. Cohen points out that trials within rheumatoid arthritis (RA) and psoriasis have established outcome measures that are considered more sensitive to detect a difference in the biosimilar and the reference molecule than inflammatory bowel disease, which is why sponsors have chosen to test their biosimilars in RA and psoriasis.

The ACR states that it “does not support automatic extrapolation. We do believe that extrapolation should be rigorously studied and fully utilized to help reduce the cost of these drugs. Throughout the biosimilar approval process, care must be taken to ensure that a drug pursuing interchangeability has successfully demonstrated extrapolation for all indications for which the originator is approved.”

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Extrapolation of indications is supported by 10 years of safety and efficacy experience in Europe, Dr. Worthing says.

Pricing

Naturally, pricing of biosimilars is an issue of concern for insurers, manufacturers, physicians and patients. Dr. Gravallese believes that pricing is an important topic to address in any U.S. analysis of the role of biosimilars, including the upcoming ACR white paper.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

“I would like to see biosimilars be used, because this will potentially lead to a lower medication cost. That’s something many of us would like to see happen,” Dr. Gravallese says.

One advantage of biosimilars so far is their cost, typically 15% lower than their reference product; however, Dr. Kay has seen examples of reference products that have been discounted to below the price of their biosimilars. “If that happened all the time, it might drive biosimilars out of the market. The survival of biosimilars is necessary to maintain a competitive marketplace and keep down the cost of effective therapies so that they are affordable for our patients,” he says.

In June, the U.S. Supreme Court overturned a lower court’s ruling that prevented Novartis from selling the biosimilar Neuopogen for six months after the U.S. FDA approval. That ruling is expected to help acceleration the entry of more biosimilars into the U.S. market, many predict.

ACR White Paper

To help address the issues mentioned above in the U.S. market, the ACR decided to produce a white paper on the topic of biosimilars. The rheumatologists quoted in this article are involved in the production of the white paper, as are a handful of others. Although there was originally talk about writing a review article on biosimilars, a paper that focuses on concerns specific to the use of biosimilars in the U.S. would likely be more beneficial, Dr. Gravallese points out.

Page: 1 2 3 4 5 | Single Page
Share: 

Filed under:Biologics/DMARDsDrug Updates Tagged with:AC&Radverse eventsAmerican College of Rheumatology (ACR)BiosimilarsBiosimilars in the EUdrugefficacyEuropeEuropean UnionfindingsinterchangeabilityMedicationoutcomepatient carepricingreportRheumatic DiseaserheumatologistsrheumatologySafetyTreatment

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.

    Biosimilars Debate Heats up over Cost Savings, Safety Concerns

    Biosimilars Debate Heats up over Cost Savings, Safety Concerns

    April 15, 2016

    After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…

    The Biosimilars Debate Heats Up: Potential cost savings weighed against patient health & safety

    March 1, 2016

    After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…

    Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

    September 8, 2016

    The use of biosimilars for rheuma­tology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…

  • 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