Gottlieb describes innovation office, biosimilars policies at JPM

FDA Commissioner Scott Gottlieb described plans to create a new office dedicated to advancing innovation in drug development, and telegraphed upcoming initiatives aimed at facilitating competition from biosimilars and generic drugs in remarks delivered to the J.P. Morgan Healthcare Conference.

Forthcoming guidance will include a structured application for biosimilars manufacturers to seek designations that their products are interchangeable with original biologics, Gottlieb said. The lack of guidance has prevented sponsors from seeking interchangeability. ...