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  3. Claims & Support/References for Claims
  4. Use of Biosimilar-Specific Stability Data
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

Use of Biosimilar-Specific Stability Data

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • C Offline
    C Offline
    cscholes
    wrote last edited by
    #1

    Can we use a stability study designed for our biosimilar since the reference drug information in the product monograph does not reflect our data? Are there exceptions to the standard requirement of reflecting the product monograph for biosimilars?

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    • Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote last edited by
      #2

      Hey @cscholes

      Claims within advertising for biosimilars must meet the same rigors of the Code as other products. Studies from outside of the TMA must be consistent with the TMA. They must also meet PAAB Code requirements for evidence e.g. well-designed, published, peer-reviewed, statistically supported claims based on predefined endpoints, on label, etc.). If you’re not certain if a specific study meets those requirements, we encourage you to submit for an opinion review. Please be specific about how you’d like to use the study in order to receive the most comprehensive opinion.

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