• 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 » Physicians wary of using biosimilars

Physicians wary of using biosimilars

August 24, 2011
CenterWatch Staff

Decision Resources finds that the majority of U.S. and European physicians are wary of using a biosimilar for an indication for which supporting clinical data are lacking. According to new analysis, physician attitudes about indication extrapolation-where a biosimilar needs only to show similarity in a phase III study for one indication, and it will be granted approval for other indications for which the branded product is used-vary by country. French physicians are the most conservative when asked about indication extrapolation when compared to German and U.S. physicians.

Analysis from Biosimilars Advisory Service: Acceptance of Biosimilars Across Physician Specialties also finds that surveyed rheumatologists, nephrologists and gastroenterologists in particular say indication extrapolation should not be allowed or should be done carefully because of minute differences between the biosimilar and the branded product that may be clinically significant.

"It's not surprising to see that rheumatologists, nephrologists and gastroenterologists we surveyed are wary of indication extrapolation as these specialists have expressed a moderately conservative approach to biosimilars," said Decision Resources analyst Edward Wydysh, Ph.D. "To meet physician expectations, biosimilar manufacturers will most likely need to conduct clinical trials in several indications, which may be cost-prohibitive for a smaller company to enter the market. If a biosimilar manufacturer with fewer resources wants to compete with an original biologic in more indications, it should focus on therapeutic areas and drug classes that surveyed physicians find most acceptable for extrapolation, for instance granulocyte colony stimulating factors, or G-CSFs, in oncology."

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

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

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