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Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances

Executive Summary

Draft guidelines on interchangeability and statistical considerations due by end of 2017, suggesting long-awaited documents may not see the light of day this year as many had hoped.

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Avoiding ‘Groundhog Day’: US FDA’s Biosimilar Action Plan Applies Lessons From Generic Competition

“We’re not going to wait a decade or more for robust biosimilar competition to emerge,” Commissioner Scott Gottlieb says, noting reference biologic sponsors are repeating some of the delay tactics honed in the small molecule space to keep competition at bay.

Avoiding ‘Groundhog Day’: US FDA’s Biosimilar Action Plan Applies Lessons From Generic Competition

“We’re not going to wait a decade or more for robust biosimilar competition to emerge,” Commissioner Scott Gottlieb says, noting reference biologic sponsors are repeating some of the delay tactics honed in the small molecule space to keep competition at bay.

US FDA To Sponsors: Tell Us More About Your Drug Development Before We Meet

Requests for meetings with FDA staff about products in development should include pertinent details about pediatric study plans, human factors engineering plans and combination product information; new guidance documents on formal meetings under PDUFA VI and communications with IND sponsors operationalize user fee program commitments and will promote earlier, more thorough engagement, agency says.

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