• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Amgen presents phase III study results for biosimilar ABP 501

Amgen presents phase III study results for biosimilar ABP 501

November 11, 2015
CenterWatch Staff

Amgen has presented detailed findings from a head-to-head phase III study comparing the safety, efficacy and immunogenicity of biosimilar candidate ABP 501 with adalimumab in patients with moderate-to-severe rheumatoid arthritis.

The study met the primary endpoint, which was achievement of ACR20 (20% or greater improvement in ACR assessment) at week 24. At week 24, 74.6% of patients in the ABP 501 group and 72.4% in the adalimumab group met the ACR20 response criteria. The risk ratio of ACR20 was 1.039 with the two-sided 90% = CI of 0.954-1.133, which fell within the predefined equivalence margin.

"Demonstrating biosimilarity is scientifically complex, but Amgen's 35 years of proven biologic R&D experience is facilitating the advancement of exciting programs like ABP 501," said Sean E. Harper, M.D., executive vice president of R&D at Amgen. "Our long-term commitment to advancing care in inflammation is as strong as ever, with a portfolio of novel and biosimilar compounds that have the potential to benefit patients worldwide."

ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe plaque psoriasis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis.

Secondary endpoints included the achievement of ACR50 and ACR70 (a 50 or 70% improvement in ACR assessment) within the predefined equivalence margin. At week 24, patients treated with ABP 501 compared with those treated with adalimumab achieved ACR50 (49.2% percent v. 52%) and ACR70 (26% vs. 22.9%), respectively. Additionally, the secondary endpoint of a difference in change from baseline of DAS28-CRP (Disease Activity Score examines 28 joints in the body as measured by C reactive protein in the blood) over the entire study was also achieved. The difference in mean change from baseline in DAS28-CRP between ABP 501 and adalimumab was -0.01 (90% CI, -0.18 to 0.17) at week 24.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing