While the Biologics Price Competition and Innovation Act (BPCI) was originally enacted under the Obama Administration as part of the Affordable Care Act, it appears that the Trump Administration will continue to take steps to promote and foster the development of biosimilars as part of a larger policy effort to make drugs and biological products more affordable for patients. In particular, the Centers for Medicare & Medicaid Services (CMS) has established new payment and coding policies for biosimilars reimbursed by Medicare. More recently, the Bipartisan Budget Act of 2018 includes a provision to reduce patient cost sharing for biosimilars under the Medicare Part D Prescription Drug Benefit.

At the same time, the Food and Drug Administration (FDA) Commissioner Scott Gottlieb has also made approval of biosimilars under the BPCI a priority for FDA, noting that the “cost of prescription drugs is an ongoing concern, however, a growing market for potentially lower-cost biological products called biosimilars can offer more competition and options for patients.” To that end, FDA plans to release a Biosimilar Innovation Plan to streamline the regulatory process for the abbreviated licensure pathway for biosimilars established by BPCI, and improve incentives for biosimilar adoption this year. These points were underscored by a recent White House report by the Council of Economic Advisors (CEA) advocating for the accelerated release of guidelines for demonstrating biosimilar interchangeability as a way to increase competition in the biological product space and lower drug prices.