Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team at CDER, recently participated in a podcast on biosimilars. During the discussion, she provided a “snapshot” of the biosimilar landscape at FDA.
According to Dr. Christl, as of February 1, 2017, there are 64 programs enrolled in the biosimilar development program, and CDER has received meeting requests for 23 different reference products. Pending applications are confidential. However, since program inception through February 1st of this year, nine different companies have publicly announced the submission of 13 BLAs using the 351(k) pathway.
Dr. Cristl also discusses communicating with TBBS, summarizes FDA’s policy on Advisory Committee meetings for biosimilars, and looks ahead at interchangeability and BsUFA II. The podcast is available here from Pharma Intelligence.