There will soon be a new director of Therapeutic Biologics & Biosimilars Staff (TBBS) in the Office of New Drugs (OND) at the FDA. Dr. Sarah Yim will become the new acting director of TBBS beginning in March. Dr. Yim joined the FDA in 2005 and is currently the director of the Division of Clinical Review in the Office of Bioequivalence (OB), Office of Generic Drugs (OGD).
To date, 17 biosimilars have been approved by the FDA during the tenure of the current director, Dr. Leah Christl. Dr. Christl has been with the FDA since 2003 and played an active role in developing, interpreting, and implementing the BPCIA. She will be leaving on February 22, 2019 to join Amgen’s Global Regulatory and R&D Policy group as executive director as of March 11, 2019.