The Majority of U.S. and European Physicians Are Wary of Using a Biosimilar for an Indication for Which Supporting Clinical Data

French Physicians are the Most Conservative When Asked About Indication Extrapolation, According to New Research from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)--Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, 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 Specialtiesalso 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."

The Acceptance of Biosimilars Across Physician Specialties module offers extensive primary research to examine physician attitudes towards biosimilars across the United States, France and Germany. It is offered as part of Decision Resources' Biosimilars Advisory Service which provides insight and analysis of the evolving biosimilars market.


 Members of the media are welcome to attend our upcoming webinar entitled Anticipated Uptake of Biobetters by Physician Specialty: What Do Physicians' Attitudes Toward Biobetters Indicate About Their Likelihood of Using Biosimilars? This webinar will be held on Wednesday, August 31 at 10 a.m. U.S. Eastern Time. For more information, please contact Lisa Osgood at 781-993-2606 or by e-mail at [email protected]

About the Biosimilars Advisory Service

 The Biosimilars Advisory Service provides insight and analysis that's vital to successful business planning in the rapidly evolving biosimilars space. The service includes quarterly webinars detailing major developments, analyst insight addressing key market changes and opportunities and therapeutic area-specific primary research and forecasting modules.

About Decision Resources

 Decision Resources ( is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

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