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GEN Poll

December 16, 2011

User Fees for Biosimilars

FDA is holding a public meeting to fine-tune the fees biosimilar developers must pay for the federal fiscal years 2013 through 2017. It is hoped that steps to define user-generated funding for the biosimilar approval program will aid FDA in fulfilling its of creating a biosimilars pathway that balances innovation and consumer interests. FDA envisions creating four categories of user fees. Biosimilar product development (BPD) fees of 10% of the fee established for a drug under PDUFA will be collected, starting when sponsors submit an IND or meet with FDA and for every year after until the sponsor submits a marketing application or ends participation in BPD. Second, at marketing application submission, sponsors would pay fees equal to those established under PDUFA minus the BPD fees paid. The final two fee categories are establishment fees and product fees, both of which would be equal to those paid by drug developers under PDUFA. Do you think this structure will work?

Do you agree with FDA’s new framework covering user fees and performance goals for biosimilar developers?

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