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.
The proposed Office of Drug Evaluation Science is part of a larger effort to “change the whole contour of how we do drug review,” Gottlieb told the J.P. Morgan conference.
Gottlieb described the proposed new office in an interview Monday with BioCentury. It will, he said, create tools that would make it less expensive and risky to create new drugs. “The whole reason the cost of drug development is high is that the science of prediction is costly and uncertain. We think these tools can help us better define the science of prediction.”
The Office of Drug Evaluation Science, which would have an initial staff of about 51, would be located in the Center for Drug Evaluation and Research’s Office of New Drugs. It would have divisions dedicated to promoting the development and implementation of clinical outcome assessments, biomedical informatics and safety analytics, and biomarker development.
The office would focus FDA resources on the development of tools that sponsors can use to develop drugs, and also on creating tools for FDA to improve its review activities, Gottlieb told BioCentury…