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Is the FDA stalling on biosimilars?

Lawmakers want the FDA to move quickly when it comes to biosimilars.

Lawmakers are calling on the FDA to quickly approve the use of biosimilars.

“Healthcare reforms need to be patient-focused,” said Rep. Gus Bilirakis (R-Fla.). “Too often the regulatory structure in place gets in the way of innovation.”

Bilrakis' comments were made during an event this week hosted by The Hill and sponsored by Express Scripts.

Sally Howard, the agency’s Deputy Commissioner for Policy Planning and Legislation said the agency is very supportive of the biosimilars market, as it could cut prescription drugs by 30 to 50 percent.

"Two companieshave publicly announcedthat they’ve submitted applications for biosimilars and those are under review," she told The Hill. “There’s no additional guidance needed before an application can be approved.”

There was however, concern over whether or not Medicaid would be able to afford copycat he biological drugs.

The need for the FDA to address health and safety issues, as well as give guidance on naming biosimilars were brought up during the Thursday panel event.

“Our goal as an agency is to instill confidence in these products and this industry,” Howard said.

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