Posted by Michael Wonder on 01 Mar 2018
Friction in the path to use of biosimilar drugs
1 March 2018 - Enactment of the Biologics Price Competition and Innovation Act in 2010 raised expectations that new competition would blunt price increases for biologic drugs.
The Act defined an expedited pathway for biosimilars — products that are similar to and have no clinically meaningful differences from a biologic product approved by the FDA — to compete with biologics that no longer have patent or regulatory market exclusivity.
The expectations for increased competition were based on the experiences in Europe and estimates made by the Congressional Budget Office and private analysts.
