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FDA may push back release of biosimilar interchangeability draft guidance

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FDA has said that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, but the just-released user fee reauthorization commitment letter states the draft will publish sometime before the end of 2017.

FDA has said that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, but the just-released user fee reauthorization commitment letter states the draft will publish sometime before the end of 2017. The letter, which contains the performance goals and procedures for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal years 2018–22, also says that FDA will work toward the goal of publishing a revised draft or final guidance on interchangeability within 2 years after the close of the public comment period of the draft, meaning the final interchangeability guidance may not take effect before 2019.

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http://www.raps.org/Regulatory-Focus/News/2016/09/22/25885/FDA-May-Push-Back-Release-of-Biosimilar-Interchangeability-Draft-Guidance/

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