7:39 AM
Jan 08, 2019
 |  BC Extra  |  Politics & Policy

Gottlieb describes innovation office, biosimilars policies at JPM

Editor's Note: This article was updated on Jan 08, 2019 at 1:52 PM PST

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.

The agency is also looking for ways to legally allow interchangeable biologics and biosimilars to be compared to biologics that are sourced outside the U.S. if the original biologics are identical to those sold in the U.S., Gottlieb said. This could dramatically reduce the cost of developing interchangeables and biosimilars, as procurement of reference biologics for analytical tests and clinical trials constitutes a major portion of development costs.


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