A Turning Point for US Biosimilars
The next 12–18 months could be a critical time for biosimilars in the United States (1). This product class has grown rapidly since passage of the Biosimilars Price Competition and Innovation Act (BPCIA) of 2010. That landmark legislation allowed for biosimilar market approvals based on previously approved “reference products,” creating an expedited pathway that reduces biosimilar development costs and speeds regulatory review so patients get faster access to essential medicines. Increased competition from biosimilars could save the US healthcare system billions of dollars. Both regulators and the judiciary are now revisiting important aspects of BPCIA, and their decisions will help determine the full market potential of this product class.