Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018.
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years. Global sales for the top nine branded biologic drugs were estimated to total $63 billion in 2016.
Competition in the heavily regulated marketplace for these blockbuster therapeutics is expected to substantially impact the pharmaceutical industry and national health systems. To date, the U.S. has considerably lagged behind Europe’s expansion of biosimilar drug options. The RAND Corporation estimates that biosimilar products can save the U.S. health system approximately $54 billion over the next decade, as discussed here.
