In July 2018, the FDA published the Biosimilars Action Plan (BAP), which outlined the FDA’s approach to expanding access to biosimilars for the American public. The plan focused on 4 key areas:
A recent FDA report Check out some of his achievements since then. Most of these efforts revolve around guidance documents, additional staff, educational products and websites, public hearings, and regulations (i.e., proposed/final rules). The FDA also added new data resources, including publishing a modernized version of the Purple Book in February 2020. The FDA also collaborated with other agencies such as the FTC, produced a joint statement, and held a workshop in March 2020, titled: “Public Workshop: FDA/FTC Workshop on a Competitive Market for Biosimilars.” Some other key actions are listed below.
The full report is here.
