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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 the House Energy and Commerce Subcommittee on Health.

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