FDA Meeting on the Approval Pathway for Biosimilars and Interchangeable Biological Products Scheduled for November 2-3
Michael Malecki, Ph.D., head of biosimilars research for Decision Resources, is available to discuss the biosimilars market, both in the U.S. and abroad. On November 2 and 3, the U.S. Food and Drug Administration (FDA) will host a meeting to discuss the approval pathway for biosimilars and interchangeable biological products. Dr. Malecki can provide background for articles written ahead of the FDA meeting, or provide comment following the meeting.
Dr. Malecki has spoken on topics relating to commercial aspects of biosimilars at numerous international conferences and can address the following areas:
- FDA Approval Process for Biosimilars. U.S. healthcare reform contained provisions that will affect biologics and biosimilars. What is the likely approval process for biosimilars in the United States? What lessons can be learned from regulatory processes in Europe and past European launches of biosimilars?
- Biosimilars Market Overview. Decision Resources forecasts biosimilars revenue across the U.S. and EU5 markets alone will total more than $45 billion between now and 2019. Which companies have emerged as major players in the biosimilars space? Which companies have recently entered this space? Which brands stand to lose the most ground to biosimilars?
- Payer Perspectives on Biosimilars. The extent to which payers actively promote the use of biosimilars will affect uptake of these agents and concomitant erosion of brand sales. However, the mechanisms by which payers will promote biosimilars will vary by drug class, treatment setting and reimbursement environment. Which classes are top priorities for payers to reduce spend on biologics and how have these priorities evolved over time? What are the barriers to entry for biosimilars?
- Physician Attitudes and Biosimilar Uptake. Physician awareness and attitudes toward the prescription of biosimilars will certainly impact their uptake, as well as the defense of currently marketed drugs from biosimilars erosion. Which physician specialties indicate the greatest future acceptance of biosimilars? How do physician expectations in the U.S. vary from their European counterparts?
To speak with Dr. Malecki, please contact Lisa Osgood at 781.993.2606 or [email protected] .
About Decision Resources
Decision Resources (www.decisionresources.com) 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, Inc. company.
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/PRNewswire -- Nov. 1, 2010/
SOURCE Decision Resources