Biosimilars: 2014 in review and what to expect in 2015

The past year has seen an accelerated pace of developments and refinements in interpretation and application of the Biologics Price Competition and Innovation Act, including licensure of the first biosimilar in the United States. But even with new FDA guidances and court decisions, a number of salient issues remain open. This article presents a brief summary of the past year and an outline of what to expect in the future, as additional biosimilar applications follow on the heels of the first licensure.