Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that over two-thirds of surveyed managed care organizations' (MCO) pharmacy directors cite erythropoiesis stimulating proteins (ESPs) and TNF-alpha inhibitors as the top priority biologic classes they would replace with biosimilars in their formularies to reduce spending, owing to the high cost of branded agents in these classes. Eighty-four percent of surveyed MCO directors said they will incorporate a biosimilar ESPs into their formulary within a year of the drug's launch. Additionally, 67 percent of MCO directors said they will incorporate a biosimilar TNF-alpha inhibitor into their formulary within a year of the drug's launch.
According to the new special report entitled Biosimilars 2007-2017: Shifting Payer and Physician Opinion Increases the Hurdles to Uptake, the agreement among MCOs to reimburse biosimilar ESPs and TNF-alpha inhibitors is due the significant commercial success of the branded agents in these drug classes. In 2007, Amgen/Wyeth/Takeda's Enbrel, Centocor/Schering-Plough/Mitsubishi Tanabe's Remicade, Abbott/Eisai's Humira (all TNF-alpha inhibitors), as well as Amgen's Epogen and Aranesp and Johnson & Johnson's Procrit (all ESPs), had combined total sales of $13.7 billion in the United States alone. Although biosimilars may ultimately reduce costs for MCOs, manufacturers of branded biologic agents facing biosimilar competition are at risk of significant losses.
"We anticipate that Abbreviated Biologic License Application-approved biosimilars will begin to enter the U.S. market in 2013. Amgen is the most vulnerable to the biosimilar threat as no other company has as many top-tier biologic agents facing near-term patent expiry," said Nicole Westphal, Ph.D., analyst at Decision Resources. "In 2007, five therapeutic recombinant proteins drove Amgen's success: Enbrel, Epogen, Aranesp, Neupogen and Neulasta. Over the next 10 years, biosimilars will significantly reduce global sales of all of these products."
The report finds that, of the top 100 best-selling drugs in 2007, biologics accounted for 25 percent of total drug sales and 13 of the leading biologics achieved mega blockbuster status: more than $2 billion in worldwide sales. Owing to the significant market opportunity that biologics represent, pharmaceutical companies are increasingly turning to these agents to fill their pipelines. However, the emergence of a biosimilars market in the United States and Europe threatens branded off-patent biologics sales which are expected to surpass $55 billion by 2017, according to the report.
About the Report
Biosimilars 2007-2017: Shifting Payer and Physician Opinion Increases the Hurdles to Uptake covers 18 key biologic brands from seven biologic classes and includes surveys of 402 U.S. and European physicians and 40 MCO pharmacy directors.
About Decision Resources
Decision Resources (http://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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