The development of biosimilars represents an important opportunity to make biologic drugs more accessible. Increased product competition may lead to lower prices and help hold down health care costs, according to the Generic Pharmaceutical Association (GPhA). But no one knows how quickly or how widely biosimilars will become available – or how much they will cost.
The Biologics Price Competition and Innovation Act of 2009 established a pathway for biosimilar drugs to be reviewed and approved by the U.S. Food and Drug Administration (FDA). This act was signed into law as part of the Affordable Care Act of 2010, and cleared by the U.S. Supreme Court in June 2012. In just a few short months, this pathway will finally go "live."
Will the approval pathway result in a rich pipeline of new biosimilar drugs? And if it does, will these biosimilars prove effective at bringing down the cost of biologic medicines and specialty drug spending?
In this white paper, Prime offers insight into the unresolved questions that will affect biosimilar availability, management and costs.
 Generic Drug Savings in the U.S. Generic Pharmaceutical Association. 2012. Available at http://www.gphaonline.org/media//cms/IMSStudyAug2012WEB.pdf