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Woodcock: Biosimilars Program Lacks Funding, Will Explode

 
• By Donna Young

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), told lawmakers on Feb. 4 she was concerned the agency's biosimilars program "is going to explode" because it lacks funding and resources, with the anticipation the agency could be facing a multitude of applications it's unprepared to handle.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), told lawmakers on Feb. 4 she was concerned the agency's biosimilars program "is going to explode" because it lacks funding and resources, with the anticipation the agency could be facing a multitude of applications it's unprepared to handle.

"I'm concerned we will not have the staff because we're always waiting to catch up," Woodcock told the members of...

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