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

“The ACR’s white paper on biosimilars will inform prescribers about the FDA approval process, scientific and clinical issues, such as extrapolation, immunogenicity, switching and interchangeability; and issues related to cost, access and the mechanics of prescribing,” Dr. Worthing says. “The purpose of the white paper is to inform our members about biosimilars, reassure them about the scientific rigor used by regulatory authorities and boost confidence in prescribing biosimilars.”

As of publication, this paper was still in draft form.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Vanessa Caceres is a medical writer in Bradenton, Fla.

Reference

  1. European Medicine Agencies and European Commission. Biosimilars in the EU: Information guide for healthcare professionals. 2017.

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