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Congress Frets Over Slow Pace of Biosimilar Licensing

Kate Traynor

BETHESDA, MD 04 Feb 2016—FDA came under fire today from members of the House of Representatives who were critical of the agency's seemingly slow pace in approving biosimilar drugs and failure to provide manufacturers with timely guidance on developing these biological products.

Although legislation was enacted six years ago to create an abbreviated pathway for the licensing of biosimilars, FDA has approved just one such product so far—Zarxio, a biosimilar version of filgrastim made by Sandoz. And guidance documents on the development, marketing, and naming of biosimilars have not yet been released.

"It's time for FDA to get on down the road and decide exactly how to proceed with the approval process," said Texas Rep. Joe Barton, during a hearing this morning of the House Committee on Energy and Commerce's subcommittee on health.

FDA is scheduled to take a step on that road February 9, when the agency's Arthritis Advisory Committee members will discuss Celltrion, Inc.'s marketing application for a biosimilar version of infliximab.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, acknowledged the importance of biosimilars to patients and others who are concerned about the access to these potentially lifesaving medications. Woodcock also agreed that manufacturers need to know more about the agency's expectations and requirements for product licensure.

"I know people are anxious to see more progress and more certainty," Woodcock said.

She said that there has been "a lot of progress" on biosimilars since 2010, but much of that progress has been "under the hood."

"To earn and to sustain both physician and patient confidence in biosimilars and interchangeable products, we must apply a scientifically rigorous review process and approval standard that people believe in and trust," Woodcock said.

She said FDA has worked with manufacturers on nearly 60 biosimilar development programs so far. And she said the agency is aware of "perhaps several dozen" additional development programs that are underway.

Although she predicted that there is "a bright future ahead" for FDA's biosimilars pathway, Woodcock acknowledged, when pressed by New Jersey Rep. Frank Pallone, that a lack of resources has affected the agency's progress on biosimilars.

"Congress did not appropriate any additional funding for us to do the biosimilar program," Woodcock said. She also explained that the user fee program for biosimilars, which was authorized in 2012, was established with $20 million that came out of FDA's budget.

"That was not additional funds—that was funds we had to take from other activities," she said. "Had we had more staffing and funding at the get-go, we could have set up a program in 2010 [so] that we would have been better off now."

Woodcock said FDA has collected about $43 million in biosimilar program user fees since fiscal year 2013, and she said FDA will be able to improve the biosimilars pathway as funding from user fees increases.

But she also sounded a note of caution about the agency's work with biosimilars.

"What I am concerned about is that this program is going to explode—that we're going to have...multiple entries, potentially, for many of the existing biosimilars," Woodcock said. "And I'm concerned that we will not have the staff because we're always waiting to catch up."

 

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