Blog Post

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

MoFo Life Sciences

25 Oct 2021

On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.”  The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria that help determine sameness of human gene therapy products for orphan drug designation and exclusivity purposes.  In the Federal Register notice announcing the final guidance, FDA noted that it received comments on the draft guidance that “generally supported the approach described in the guidance.”  FDA considered these comments and requests for additional clarification when finalizing the guidance, “adding clarification and examples, as feasible.”

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