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.
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Use of Biosimilar-Specific Stability Data
Claims & Support/References for Claims
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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.
