Regulation

FDA’s Biosimilars Action Plan

In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas:

A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites, public hearings and regulations (i.e., proposed/final rules). FDA also added new data resources including publishing a modernized version of the Purple Book in February 2020. FDA also collaborated with other agencies such as FTC, and produced a joint statement and held a workshop in March 2020, entitled: “Public Workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” Some other key actions are listed below.

The full report is here.