To Feel Comfortable with Biosimilars, Surveyed U.S. Payers Will Likely Require More Clinical Information Than What Might B

TNF-Alpha Inhibitors are Payers’ Top Priority for Reducing Biologic Spend, 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 to feel comfortable with biosimilars, surveyed U.S. payers will likely require more clinical information than what might be accepted by the U.S. Food and Drug Administration (FDA) for biosimilar approval. For instance, FDA approval of biosimilar versions of monoclonal antibodies for oncology indications will not allay all the concerns the majority of payers have about bioequivalence.

According to primary research findings from U.S. and EU Payer Perspectives: What are the opinions of U.S. and European payers on biosimilars pricing, uptake, and reimbursement?, surveyed U.S. payers also indicate that six to 12 months clinical trial duration is insufficient to convince them that a biosimilar has equivalent efficacy and safety to the originator biologic for monoclonal antibodies or fusion proteins.

“Because monoclonal antibodies are highly complex biologics compared with more simple proteins, FDA approval will only go part way in satisfying payers’ doubts over these more elaborate agents,” said Biosimilars Advisory Service Director Andrew Merron, Ph.D. “Overall, biosimilar manufacturers developing biosimilar monoclonal antibodies will need to invest in trials lasting at least one year to convince the majority of payers about bioequivalence.”

The analysis also finds that both U.S. and European payers identify tumor necrosis factor (TNF)-alpha inhibitors as their top priority for reducing biologic spend.

“TNF-alpha inhibitors represent a major cost burden to payers, so this class of biologic may receive greater pressure to prescribe biosimilars compared with other biologic classes,” added Dr. Merron.


Members of the media are welcome to attend our upcoming webinar entitled How Will Payer Opinions Shape the Future Commercial Potential of Biosimilars and Branded Biologics in the United States and Europe? This webinar will be held on Thursday, August 18 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.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.


Decision Resources
Lisa Osgood, 781-993-2606
[email protected]
Decision Resources Group
Christopher Comfort, 781-993-2597
[email protected]

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:   Health  Pharmaceutical  General Health