In July 2018, the FDA released the Biosimilar Action Plan (BAP), which outlines the FDA's approach to expanding access to biosimilar drugs to the American public. The plan focuses on 4 key areas:
recent FDA report A look back at some of their achievements since then. Much of these efforts revolve around guidance documents, additional staff, educational products and websites, public hearings, and regulations (i.e., proposed/final rules). FDA has also added new data resources, including releasing a modernized version of the Purple Book in February 2020. Titled: “Public Seminar: FDA/FTC Seminar on Competitive Markets for Biosimilars”. Some other key actions are listed below.
The full report is here.
